Primary Device ID | 00385640002431 |
NIH Device Record Key | 3cf8a190-0408-47dc-b77f-33e45cd1047e |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | EP-1010 |
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 | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00385640002431 [Primary] |
MJV | Device, Inflation, Middle Ear |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-26 |
Device Publish Date | 2021-05-18 |
00385640087513 - INSTRUSAFE | 2025-07-03 |
00385640087506 - INSTRUSAFE | 2025-07-02 |
00385640087483 - INSTRUSAFE | 2025-07-01 |
00385640087490 - INSTRUSAFE | 2025-07-01 |
00385640087476 - INSTRUSAFE | 2025-06-27 |
00385640087469 - INSTRUSAFE | 2025-06-26 |
00385640087421 - INSTRUSAFE | 2025-06-25 |
00385640087438 - INSTRUSAFE | 2025-06-25 |