| Primary Device ID | 07290110726966 |
| NIH Device Record Key | 11da4fc2-7cf9-43e9-af6b-3524c7bf6d26 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRX-OP |
| Version Model Number | LP-S |
| Catalog Number | LP-S |
| Company DUNS | 600710917 |
| Company Name | HI-TEC IMPLANTS LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290110726966 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-12 |
| 07290110727512 | IMPLANT ANALOG |
| 07290110727505 | IMPLANT ANALOG |
| 07290110726973 | NYLON COPING |
| 07290110726966 | NYLON COPING |
| 07290110726959 | NYLON COPING |
| 07290110726942 | NYLON COPING |
| 07290110723019 | HEALING CAP |
| 07290110723002 | HEALING CAP |
| 07290110722050 | DENTAL IMPLANT |
| 07290110722043 | DENTAL IMPLANT |
| 07290110722036 | DENTAL IMPLANT |
| 07290110722029 | DENTAL IMPLANT |
| 07290110722012 | DENTAL IMPLANT |
| 07290110722005 | DENTAL IMPLANT |