HARKEN ASSURE SELF-SEAL STERILIZATION POUCH
Device Facts
| Record ID | K945055 |
|---|---|
| Device Name | HARKEN ASSURE SELF-SEAL STERILIZATION POUCH |
| Applicant | Harken Products, Inc. |
| Product Code | KCT · General Hospital |
| Decision Date | Dec 14, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Regulatory Classification
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.
