| Primary Device ID | 00850058951256 |
| NIH Device Record Key | 5bb25da0-06f1-4741-afa9-ed1e5dc886af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amtouch Orthodontic Kit |
| Version Model Number | Orthodontic Kit (8pc) |
| Catalog Number | AMOHK-AD |
| Company DUNS | 180611519 |
| Company Name | AMERICAN MEDICAL & HOSPITAL SUPPLY CO., 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850058951256 [Primary] |
| EFW | Toothbrush, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-25 |
| Device Publish Date | 2024-10-17 |
| 00850058951232 - Amtouch Toothbrushes | 2024-10-25 Disposable Toothbrushes - Prepasted - Adult (100/Box) |
| 00850058951249 - Amtouch Dental Kit | 2024-10-25 Dental Hygiene Kit (5pc) |
| 00850058951256 - Amtouch Orthodontic Kit | 2024-10-25Orthodontic Kit (8pc) |
| 00850058951256 - Amtouch Orthodontic Kit | 2024-10-25 Orthodontic Kit (8pc) |
| 00850058951355 - Amtouch Orthodontic Flosspicks | 2024-10-25 Orthodontic Flosspicks - White (30/pk) |
| 00850048528864 - Amtouch Air/Water Syringe Tips | 2024-10-16 Air/Water Syringe Tips - Metal Core/White Tube - White (250/Bag) |
| 00850048528901 - Amtouch Air/Water Syringe Tips | 2024-10-16 Air/Water Syringe Tips - Color Core/Clear Tube - Assorted (250/Bag) |
| 00850048528918 - Amtouch Air/Water Syringe Tips | 2024-10-16 Air/Water Syringe Tips - Color Core/Clear Tube - Assorted (1000/Bag) |
| 00850058951263 - Amtouch Intraoral Tips | 2024-10-16 Intraoral Tips - Yellow (100/Bag) |