[45 FR 69721, Oct. 21, 1980] § 880.6200 Ring cutter. (a) Identification. A ring cutter is a device intended for medical purposes that is used to cut a ring on a patient's finger so that the ring can be removed. The device incorporates a guard to prevent injury to the patient's finger. (b) Classification. Class I general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device also is exempt from the good manufacturing practice regulation in Part 820 with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69722, Oct. 21, 1980] § 880.6230 Tongue depressor. (a) Identification. A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. If the device is not labeled or otherwise represented as sterile, it also is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69722, Oct. 21, 1980] § 880.6250 Patient examination glove. (a) Identification. A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. If the device is not labeled or otherwise represented as sterile, it is also exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records and (a) Identification. An examination gown is a device intended for medicalTM purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. If the device is not labeled or otherwise represented as sterile, it also is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69724, Oct. 21, 1980] (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in Subpart E of Part 807. The device also is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69725, Oct. 21, 1980] § 880.6375 Patient lubricant. (a) Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. (b) Classification. Class I (general controls). [45 FR 69726, Oct. 21, 1980] § 880.6430 Liquid medication dispenser. (a) Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device also is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69727, Oct. 21, 1980] § 880.6450 Skin pressure protectors. (a) Identification. A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores). (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device also is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69727, Oct. 21, 1980] § 880.6500 Medical ultraviolet air purifier. (a) Identification. A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation. (b) Classification. Class II (performance standards). [45 FR 69728, Oct. 21, 1980] § 880.6710 Medical ultraviolet water purifier. (a) Identification. A medical ultraviolet water purifier is a device intended for medical purposes that is used to destroy bacteria in water by exposure to ultraviolet radiation. (b) Classification. Class II (performance standards). [45 FR 69728, Oct. 21, 1980] § 880.6730 Body waste receptacle. (a) Identification. A body waste receptacle is a device intended for medical purposes tht is not attached to the body and that is used to collect the body wastes of a bed patient. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device also is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69729, Oct. 21, 1980] § 880.6740 Vacuum-powered body fluid suction apparatus. § 880.6760 Protective restraint. (a) Identification. A protective restraint is a device, usually a wristlet, anklet, or other type of strap, that is intended for medical purposes and that limits a patient's movements to the extent necessary for treatment, examination, or protection of the patient. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device is also exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69730, Oct. 21, 1980] § 880.6785 Manual patient transfer device. (a) Identification. A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher. (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in Subpart E of Part 807. The divice also is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69731, Oct. 21, 1980] § 880.6800 Washers for body waste receptacles. (a) Identification. A washer for body waste receptacles is a device intended for medical purposes that is used to clean and sanitize a body waste receptacle, such as a bedpan. The device consists of a wall-mounted plumbing fixture with a door through which a body waste receptacle is inserted. When the door is closed the body waste receptacle is cleaned by hot water, steam, or germicide. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. The device also is exempt from the good manufacturing practice regulation in Part 820 with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69731, Oct. 21, 1980] § 880.6820 Medical disposable scissors. (a) Identification. Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors. (b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in Subpart E of Part 807. [45 FR 69732, Oct. 21, 1980] § 880.6850 Sterilization wrap. (a) Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. (b) Classification. Class II (performance standards). [45 FR 69732, Oct. 21, 1980] § 880.6860 Ethylene oxide gas sterilizer. (a) Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provid er that uses ethylene oxide (ETO) to sterilize medical products. (b) Classification. Class II (performance standards). [45 FR 69733, Oct. 21, 1980] § 880.6870 Dry-heat sterilizer. (a) Identification. A dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical products by means of dry heat. (b) Classification. Class II (performance standards). [45 FR 69734, Oct. 21, 1980] § 880.6880 Steam sterilizer. (a) Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam. (b) Classification. Class II (performance standards). [45 FR 69734, Oct. 21, 1980] § 880.6900 Hand-carried stretcher. (a) Identification. A hand-carried stretcher is a device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried. (b) Classification. Class I (general controls). The device is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69735, Oct. 21, 1980] § 880.6920 Syringe needle introducer. (a) Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface. (b) Classification. Class II (performance standards). [45 FR 69736, Oct. 21, 1980] § 880.6960 Irrigating syringe. (a) Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. If the device is not labeled or otherwise represented as sterile, it also is exempt from the good manufacturing practice regulation in Part 820, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69736, Oct. 21, 1980] § 880.6970 Liquid crystal vein locator. (a) Identification. A liquid crystal vein locator is a device used to indicate the location of a vein by revealing variations in the surface temperature of the skin by displaying the color changes of heat sensitive liquid crystals (cholesteric esters). (b) Classification. Class I (general controls). [45 FR 69737, Oct. 21, 1980] § 880.6980 Vein stabilizer. (a) Identification. A vein stabilizer is a device consisting of a flat piece of plastic with two noninvasive prongs. The device is placed on the skin so that the prongs are on either side of a vein and hold it stable while a hypodermic needle is inserted into the vein. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in Subpart E of Part 807. If the device 882.4150 Scalp clip. 882.4175 Aneurysm clip applier. 882.4190 Clip forming/cutting instrument. 882.4200 Clip removal instrument. 882.4215 Clip rack. 882.4250 Cryogenic surgical device. 882.4275 Dowel cutting instrument. 882.4300 Manual cranial drills, burrs, trephines, and their accessories. 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories. 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories. 882.4325 Cranial drill handpiece (brace). 882.4360 Electric cranial drill motor. 882.4370 Pneumatic cranial drill motor. 882.4400 Radiofrequency lesion generator. 882.4440 Neurosurgical headrests. (EEG) 882.4460 Neurosurgical head holder (skull clamp). 882.4500 Cranioplasty material forming in 882.4525 Microsurgical instrument. strument. |