Primary Device ID | D807100141101 |
NIH Device Record Key | 2de66943-44f0-453f-bd8d-b7653329169d |
Commercial Distribution Discontinuation | 2020-01-31 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | IN-OVATION® C |
Version Model Number | 100-141-10 |
Catalog Number | 100-141-10 |
Company DUNS | 053475903 |
Company Name | GAC |
Device Count | 5 |
DM Exempt | true |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
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 |
---|---|
HIBCC | D807100141100 [Unit of Use] |
HIBCC | D807100141101 [Primary] |
NJM | Bracket, ceramic, orthodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-01-31 |
Device Publish Date | 2017-06-26 |
D807100241101 | IN-OVATION® C RT RX 018/UL4&5 -7T0A2DHK |
D807100141101 | IN-OVATION® C RT RX 018/UR4&5 -7T0A2 HK |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() IN-OVATION 78731830 3274398 Live/Registered |
SANTA FE OPERA 2005-10-12 |
![]() IN-OVATION 75515612 2492999 Live/Registered |
DENTSPLY SIRONA INC. 1998-07-08 |