Primary Device ID | 00385640025874 |
NIH Device Record Key | 42c150cc-91b8-472b-8bcf-8eb389a59053 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INSTRSAFE |
Version Model Number | IN-2020-1331 |
Company DUNS | 965484699 |
Company Name | SUMMIT MEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00385640025874 [Primary] |
KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-08-09 |
Device Publish Date | 2016-12-28 |
00385640082303 - INSTRUSAFE | 2024-08-16 |
00385640082310 - INSTRUSAFE | 2024-08-16 |
00385640082327 - INSTRUSAFE | 2024-08-16 |
00385640082334 - INSTRUSAFE | 2024-08-16 |
00385640082341 - INSTRUSAFE | 2024-08-16 |
00385640082297 - INSTRUSAFE | 2024-08-15 |
00385640082266 - INSTRUSAFE | 2024-08-14 |
00385640082273 - INSTRUSAFE | 2024-08-14 |