| Primary Device ID | 07290116777689 |
| NIH Device Record Key | 4b91c195-bc49-4497-b6e0-d2640aac1487 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OnePiece Surgical Torque Ratchet 80 Ncm |
| Version Model Number | RA1080 |
| 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 | 07290116777689 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290116777689]
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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| 07290116777689 - OnePiece Surgical Torque Ratchet 80 Ncm | 2025-12-26 |
| 07290116777689 - OnePiece Surgical Torque Ratchet 80 Ncm | 2025-12-26 |
| 07290116777696 - OnePiece Surgical Torque Ratchet 200 Ncm | 2025-12-26 |
| 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 |