| Primary Device ID | 00192029049426 |
| NIH Device Record Key | 27461aa6-af01-4969-9676-df862f9a92fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tongue-Away Sheild |
| Version Model Number | 100-393 |
| Company DUNS | 005432299 |
| Company Name | TP ORTHODONTICS 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com | |
| Phone | +1(219)785-2591 |
| nicholas.smith@tportho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192029049426 [Primary] |
| FMA | DEPRESSOR, TONGUE, NON-SURGICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-17 |
| Device Publish Date | 2022-05-09 |
| 00192029049471 | Shield |
| 00192029049457 | Small, Medium, Large |
| 00192029049440 | Medium |
| 00192029049433 | Small |
| 00192029049426 | Medium |
| 00192029049419 | Medium |
| 00192029049402 | Medium |
| 00192029049396 | Medium |