Primary Device ID | 00385640029490 |
NIH Device Record Key | b4f00e31-d0ae-4ad2-9df0-5a13051f24c3 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | OM-1001-MM |
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 | 00385640029490 [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 | 4 |
Public Version Date | 2019-08-09 |
Device Publish Date | 2017-08-24 |
00385640081511 - INSTRUSAFE | 2024-06-28 |
00385640081504 - INSTRUSAFE | 2024-06-24 |
00385640081498 - INSTRUSAFE | 2024-06-21 |
00385640081481 - INSTRUSAFE | 2024-06-20 |
00385640081429 - INSTRUSAFE | 2024-06-19 |
00385640081436 - INSTRUSAFE | 2024-06-19 |
00385640081443 - INSTRUSAFE | 2024-06-19 |
00385640081450 - INSTRUSAFE | 2024-06-19 |