21 CFR 880.6850 — Wrap, Sterilization
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6850
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FRG | Wrap, Sterilization | 2 | 320 | 3rd Party |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 277 | 3rd Party |
