| Primary Device ID | 00850043387275 |
| NIH Device Record Key | 0578a223-1d2a-4337-a512-7e3c5f168164 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartSDGrip |
| Version Model Number | 7.75 |
| Company DUNS | 095652542 |
| Company Name | Implantwise LLC |
| 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 | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00850043387275 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-03 |
| Device Publish Date | 2023-01-27 |
| 00850043387282 | SmartSDGrip 7.0 mm diameter: Clip recess underside of finger dental implant screwdriver with flo |
| 00850043387275 | SmartSDGrip 7.75 mm diameter: Clip recess underside of finger dental implant screwdriver with fl |
| 00850043387268 | SmartSDGrip 8.75 mm in diameter: Clip recess of finger dental implant screwdriver with floss tet |
| 00850043387244 | SmartSDGrip 6.75 mm diameter: Clip recess underside of finger dental implant screwdriver with fl |