Primary Device ID | 10385640023679 |
NIH Device Record Key | ae80a9bb-3804-4d07-b818-852615fbd8d9 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | ET-AGDT-40 |
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 | 00385640023672 [Primary] |
GS1 | 10385640023679 [Package] Contains: 00385640023672 Package: Box [10 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 | 3 |
Public Version Date | 2021-08-23 |
Device Publish Date | 2020-11-04 |
00385640081030 - INSTRUSAFE | 2024-05-21 |
00385640081047 - INSTRUSAFE | 2024-05-21 |
00385640081023 - INSTRUSAFE | 2024-05-20 |
00385640081009 - INSTRUSAFE | 2024-05-15 |
00385640081016 - INSTRUSAFE | 2024-05-15 |
00385640080996 - INSTRUSAFE | 2024-05-14 |
00385640080972 - INSTRUSAFE | 2024-05-13 |
00385640080989 - INSTRUSAFE | 2024-05-13 |