Primary Device ID | D807310131001 |
NIH Device Record Key | f067439f-0ce4-45ab-ae8e-4404859b7c10 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ovation® C |
Version Model Number | 310-131-00 |
Catalog Number | 310-131-00 |
Company DUNS | 053475903 |
Company Name | GAC |
Device Count | 10 |
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 | D807310131000 [Unit of Use] |
HIBCC | D807310131001 [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 |
D807K310532111 | OVATION® C RT RX 022 U5-5/L3-3 CS BC HK |
D807K310531111 | OVATION® C RT RX 018 U5-5/L3-3 CS BC HK |
D807K310152111 | OVATION® C RT RX 022 U5-5 CS BC HK |
D807310611001 | Ovation® C Base Rx 018/L1&2 0T 0A |
D807310542101 | Ovation® C RT RX 022/U4&5 -7T 0A HK |
D807310542001 | Ovation® C RT RX 022/U4&5 -7T 0A |
D807310431101 | Ovation® C RT RX 018/LL3 -11T 7A 2M HK |
D807310332101 | Ovation® C RT RX 022/LR3 -11T 7A 2M HK |
D807310331001 | Ovation® C RT RX 018/LR3 -11T 7A 2M |
D807310231161 | Ovation® C RT RX SP 018/UL3-2T 9A 4M HK |
D807310231101 | Ovation® C RT RX 018/UL3 -2T 13A 4M HK |
D807310231001 | Ovation® C RT RX 018/UL3 -2T 13A 4M |
D807310221001 | Ovation® C RT RX 018/UL2 8T 9A |
D807310132101 | Ovation® C RT RX 022/UR3 -2T 13A 4M HK |
D807310132001 | Ovation® C RT RX 022/UR3 -2T 13A 4M |
D807310131161 | Ovation® C RT RX SP 018/UR3 -2T 9A 4M HK |
D807310131101 | Ovation® C RT RX 018/UR3-2T 13A 4M HK |
D807310131001 | Ovation® C RT RX 018/UR3 -2T 13A 4M |
D807310122001 | Ovation® C RT RX 022/UR2 8T 9A |
D807310121001 | Ovation® C RT RX 018/UR2 8T 9A |
D807310112001 | Ovation® C RT RX 022/UR1 12T 5A |
D807310111001 | Ovation® C RT RX 018/UR1 12T 5A |