Primary Device ID | D948SAODROL00161 |
NIH Device Record Key | f254a972-e967-46df-b9d3-6971139ac031 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SmartArch |
Version Model Number | SAO-DROL-0016 |
Company DUNS | 200106716 |
Company Name | Smarter Alloys Inc |
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 | false |
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 | D948SAODROL00160 [Primary] |
HIBCC | D948SAODROL00161 [Package] Contains: D948SAODROL00160 Package: Envelope [10 Units] In Commercial Distribution |
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 | 2021-04-13 |
Device Publish Date | 2021-04-05 |
D948SAODROU00160 | SmartArch .016" (0.406mm) Round Damon Upper Orthodontic CuNiTi Archwire |
D948SAODROL00161 | SmartArch .016" (0.406mm) Round Damon Lower Orthodontic CuNiTi Archwire |
D948SAODREU18251 | SmartArch .018 x .025" (0.457 x 0.635mm) Round Damon Upper Orthodontic CuNiTi Archwire |
D948SAODREL18251 | SmartArch .018 x .025" (0.457 x 0.635mm) Round Damon Lower Orthodontic CuNiTi Archwire |