| Primary Device ID | 07290119310258 |
| NIH Device Record Key | 2925a95e-604d-4028-b612-cac49c0d5e31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guided Surgery Drill |
| Version Model Number | 2.8mm Diameter x 8mm Length |
| Catalog Number | BIO-GD28L08 |
| 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 | 07290119310258 [Primary] |
| QRQ | Non-Irrigation Endosseous Dental Implant Drill Bits |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
[07290119310258]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-24 |
| Device Publish Date | 2025-03-14 |
| 07290119310289 | 2.8mm Diameter x 13mm Length |
| 07290119310272 | 2.8mm Diameter x 11.5mm Length |
| 07290119310265 | 2.8mm Diameter x 10mm Length |
| 07290119310258 | 2.8mm Diameter x 8mm Length |
| 07290119310241 | 2.8mm Diameter x 6mm Length |
| 07290119310234 | 2mm Diameter x 13mm Length |
| 07290119310227 | 2mm Diameter x 11.5mm Length |
| 07290119310210 | 2mm Diameter x 10mm Length |
| 07290119310203 | 2mm Diameter x 8mm Length |
| 07290119310197 | 2mm Diameter x 6mm Length |
| 07290119310432 | 4.2mm Diameter x 13mm Length |
| 07290119310425 | 4.2mm Diameter x 11.5mm Length |
| 07290119310418 | 4.2mm Diameter x 10mm Length |
| 07290119310401 | 4.2mm Diameter x 8mm Length |
| 07290119310395 | 4.2mm Diameter x 6mm Length |
| 07290119310388 | 3.65mm Diameter x 13mm Length |
| 07290119310371 | 3.65mm Diameter x 11.5mm Length |
| 07290119310364 | 3.65mm Diameter x 10mm Length |
| 07290119310357 | 3.65mm Diameter x 8mm Length |
| 07290119310340 | 3.65mm Diameter x 6mm Length |
| 07290119310333 | 3.2mm Diameter x 13mm Length |
| 07290119310326 | 3.2mm Diameter x 11.5mm Length |
| 07290119310319 | 3.2mm Diameter x 10mm Length |
| 07290119310302 | 3.2mm Diameter x 8mm Length |
| 07290119310296 | 3.2mm Diameter x 6mm Length |