| Primary Device ID | D948SAODROU00160 |
| NIH Device Record Key | d65641d4-9b50-402f-a5d5-d21129d9a958 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartArch |
| Version Model Number | SAO-DROU-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 | D948SAODROU00160 [Primary] |
| HIBCC | D948SAODROU00161 [Package] 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 |