| Primary Device ID | 07290119310005 |
| NIH Device Record Key | 843bd31e-4d9e-45c5-843f-ce791646b7ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Countersink Drill |
| Version Model Number | 4.2mm diameter x 28.3mm length |
| Catalog Number | BIO-D1034 |
| Company DUNS | 532209134 |
| Company Name | BIOLINE 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 | false |
| 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 | 07290119310005 [Primary] |
| QRQ | Non-Irrigation Endosseous Dental Implant Drill Bits |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
[07290119310005]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-19 |
| Device Publish Date | 2025-03-11 |
| 07290119310005 | 4.2mm diameter x 28.3mm length |
| 07290119310012 | 5.9mm Diameter x 28.3mm Length |