The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Gemini Titan Sterilization Wrap.
| Device ID | K192641 |
| 510k Number | K192641 |
| Device Name: | Gemini Titan Sterilization Wrap |
| Classification | Wrap, Sterilization |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-24 |
| Decision Date | 2020-01-24 |