Primary Device ID | 09359215000093 |
NIH Device Record Key | f402232d-561c-4bf6-a14d-37081e4a37a3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DentaTRAY |
Version Model Number | 05165 |
Company DUNS | 745954045 |
Company Name | ASIGA PTY LTD |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
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 | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09359215000093 [Primary] |
EBH | Material, Impression Tray, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-14 |
Device Publish Date | 2024-02-06 |
09359215000031 - DentaGUIDE | 2024-02-14 |
09359215000055 - DentaIBT | 2024-02-14 |
09359215000093 - DentaTRAY | 2024-02-14 |
09359215000093 - DentaTRAY | 2024-02-14 |
09359215000161 - DentaTRY A1 | 2024-02-14 |
09359215000178 - DentaTRY A2 | 2024-02-14 |
09359215000185 - DentaTRY A3 | 2024-02-14 |
09359215000192 - DentaTRY B1 | 2024-02-14 |
09359215000208 - DentaTRY B2 | 2024-02-14 |