Primary Device ID | D8199006522 |
NIH Device Record Key | 60f9934a-982e-4c59-875a-97eea72ee62b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lower ROC Pack for Herbst LR5 8mm |
Version Model Number | 900652 |
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 | D8199006520 [Primary] |
HIBCC | D8199006522 [Package] Contains: D8199006520 Package: [5 Units] In Commercial Distribution |
ECN | Clamp, 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 | 2023-11-07 |
Device Publish Date | 2023-10-30 |
D8199006250 - Upper ROC Kit for Herbst | 2024-04-30 |
D8199006260 - Lower ROC Kit for Herbst | 2024-04-30 |
D8199006270 - Upper Crown Kit for Herbst | 2024-04-30 |
D8199006280 - Lower Crown Kit for Herbst | 2024-04-30 |
D8199006290 - ROC Kit | 2024-04-30 |
D8199006300 - Crown Kit | 2024-04-30 |
D8199013170 - OnBrace Kit | 2024-04-30 |
D8199013182 - OnBrace Crown UR2 (5/pk) | 2024-03-18 |