Primary Device ID | 00385640001106 |
NIH Device Record Key | 7cb0192b-b2a1-42dd-ad86-5799b8436063 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | VT-0403-01 |
Company DUNS | 965484699 |
Company Name | SUMMIT MEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00385640001106 [Primary] |
GS1 | 10385640001103 [Package] Package: Box [6 Units] In Commercial Distribution |
GS1 | 20385640001100 [Package] Package: Box [50 Units] In Commercial Distribution |
ETD | Tube, Tympanostomy |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-05-06 |
Device Publish Date | 2016-09-12 |
00385640085762 - INSTRUSAFE | 2025-03-14 |
00385640085779 - INSTRUSAFE | 2025-03-14 |
00385640085786 - INSTRUSAFE | 2025-03-14 |
00385640085793 - INSTRUSAFE | 2025-03-14 |
00385640085809 - MINNE TIES | 2025-03-14 |
00385640085816 - MINNE TIES | 2025-03-14 |
00385640085823 - INSTRUSAFE | 2025-03-14 |
00385640085748 - INSTRUSAFE | 2025-03-13 |