Primary Device ID | D8199512470 |
NIH Device Record Key | 468c8946-3eca-448b-ba94-80af073669e6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | G4 NiTi Lingual Wire .010 Medium Upper |
Version Model Number | 951247 |
Company DUNS | 106645484 |
Company Name | SPECIALTY APPLIANCES, LLC |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D8199512470 [Primary] |
DZC | Wire, Orthodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-28 |
Device Publish Date | 2025-07-18 |
D8199512450 - G4 NiTi Lingual Wire .010 Small Upper | 2025-07-28 |
D8199512460 - G4 NiTi Lingual Wire .010 Small Lower | 2025-07-28 |
D8199512470 - G4 NiTi Lingual Wire .010 Medium Upper | 2025-07-28 |
D8199512470 - G4 NiTi Lingual Wire .010 Medium Upper | 2025-07-28 |
D8199512480 - G4 NiTi Lingual Wire .010 Medium Lower | 2025-07-28 |
D8199512490 - G4 NiTi Lingual Wire .010 Large Upper | 2025-07-28 |
D8199512500 - G4 NiTi Lingual Wire .010 Large Lower | 2025-07-28 |
D8199512510 - G4 NiTi Lingual Wire .013 Small Upper | 2025-07-28 |
D8199512520 - G4 NiTi Lingual Wire .013 Small Lower | 2025-07-28 |