| Primary Device ID | 08435389828952 |
| NIH Device Record Key | d786d440-6be8-4d29-94d9-8067bbbc079c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXTRACTOR FOR IMPLANTS 8 |
| Version Model Number | EXIM8 |
| Company DUNS | 461665312 |
| Company Name | BIOTECHNOLOGY INSTITUTE SL |
| 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 | 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 | 08435389828952 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08435389828952]
Moist Heat or Steam Sterilization
[08435389828952]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2026-01-30 |
| 08435389828952 - EXTRACTOR FOR IMPLANTS 8 | 2026-02-09 |
| 08435389828952 - EXTRACTOR FOR IMPLANTS 8 | 2026-02-09 |
| 08435389828969 - EXTRACTOR FOR IMPLANTS 9 | 2026-02-09 |
| 08435389829027 - SHORT DRILL; Ø2,2 MM | 2026-02-09 |
| 08435389829034 - SHORT DRILL; Ø2,3 MM | 2026-02-09 |
| 08435389829041 - SHORT DRILL; Ø2,4 MM | 2026-02-09 |
| 08435389829058 - SHORT DRILL; Ø2,0 MM | 2026-02-09 |
| 08435389829096 - FLATTENING FRONT CUTTING SHORT DRILL; Ø5.5 | 2026-02-09 |
| 08435389830061 - EXTRA SHORT INITIAL DRILL | 2026-02-09 |