| Primary Device ID | 00190730033017 |
| NIH Device Record Key | a269e98a-c5a1-42b4-85fa-e168e8f4102c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Extraoral Cheek Retractors |
| Version Model Number | 603-230 |
| Company DUNS | 781772017 |
| Company Name | ORTHO TECHNOLOGY, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
|---|---|
| GS1 | 00190730033017 [Primary] |
| EIF | ACCESSORIES, RETRACTOR, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-23 |
| Device Publish Date | 2019-05-15 |
| 00190730033017 | Retractor Extraoral HH Adult Heat Sterilizable up to 370° |
| 00190730033000 | Retractor Extraoral HH Pedo Heat Sterilizable up to 370° |
| 00190730032997 | Retractor Extraoral Aclv Adult Autoclavable up to 270° |
| 00190730032980 | Retractor Extraoral Aclv Pedo Autoclavable up to 270° |
| 00190730032973 | *Retractor Extraoral Disp Adult 10 per pack, Disposable |
| 00190730088796 | Cheek Retractor Extraoral Teen 2/pk |
| 00190730088789 | Cheek Retractor Extraoral Pedo 2/pk |
| 00190730088772 | Cheek Retractor Extraoral Adult 2/pk |