| Primary Device ID | 07290116777726 |
| NIH Device Record Key | c80a3b6e-ca1a-4827-b547-75ac8acc22cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OnePiece Pro Surgical Torque Ratchet 80Ncm |
| Version Model Number | RA2080 |
| Company DUNS | 533289435 |
| Company Name | ADIN DENTAL IMPLANT SYSTEMS LTD |
| 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 | 07290116777726 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290116777726]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-26 |
| Device Publish Date | 2025-12-18 |
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| 07290116777702 - OnePiece UniV Wrench Ratchet | 2025-12-26 |
| 07290116777719 - OnePiece Standard Prosthetic Torque Ratchet 35Ncm | 2025-12-26 |
| 07290116777726 - OnePiece Pro Surgical Torque Ratchet 80Ncm | 2025-12-26 |
| 07290116777726 - OnePiece Pro Surgical Torque Ratchet 80Ncm | 2025-12-26 |