C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES › Subpart G—General Hospital and Personal Use Miscellaneous Devices

21 C.F.R. § 880.6850

Sterilization wrap

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(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).

Notes of Decisions
Cited in 2 cases, 1989–1999 · leading case: United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F. Supp. 1159 (D. Utah 1989).
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United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F. Supp. 1159 (D. Utah 1989). “” 21 C.F.R. § 880.6850 (1988). 15 . An ethylene oxide gas sterilizer “is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.”
United States v. Bowen, 172 F.3d 682 (9th Cir. 1999). “See 21 C.F.R. § 880.6850 (sterilization wrap); 21 C.”
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