Primary Device ID | 00385640023863 |
NIH Device Record Key | 8beddb76-7b00-463f-90f6-47622b2efefa |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | EP-2100A |
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 | 00385640023863 [Primary] |
GS1 | 10385640023860 [Package] Package: BOX [12 Units] In Commercial Distribution |
GS1 | 20385640023867 [Package] Package: BOX [48 Units] In Commercial Distribution |
GS1 | 30385640023864 [Package] Package: BOX [48 Units] In Commercial Distribution |
MJV | Device, Inflation, Middle Ear |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-11 |
00385640083935 - INSTRUSAFE | 2024-11-21 |
00385640083904 - INSTRUSAFE | 2024-11-20 |
00385640083911 - INSTRUSAFE | 2024-11-20 |
00385640083928 - INSTRUSAFE | 2024-11-20 |
00385640083881 - INSTRUSAFE | 2024-11-19 |
00385640083898 - INSTRUSAFE | 2024-11-19 |
00385640083874 - INSTRUSAFE | 2024-11-18 |
00385640083836 - INSTRUSAFE | 2024-11-15 |