| Primary Device ID | 14053613293065 |
| NIH Device Record Key | bbc39ed2-3482-4ebd-aea7-35f5e984e8bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | R3FLEX 2.8mm Cannulated Drill w/ 1.6mm Steinmann Pin |
| Version Model Number | P82-912-0000-SK |
| Catalog Number | P82-912-0000-SK |
| Company DUNS | 317409001 |
| Company Name | Gebr. Brasseler GmbH & Co. KG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | 14053613293065 [Primary] |
| GFF | Bur, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-15 |
| Device Publish Date | 2025-04-07 |
| E226007158R18 - KOMET Root Canal Files | 2025-12-18 |
| E226007159R18 - KOMET Root Canal Files | 2025-12-18 |
| E226007160R18 - KOMET Root Canal Files | 2025-12-18 |
| E226007161R18 - KOMET Root Canal Files | 2025-12-18 |
| E226007162R18 - KOMET Root Canal Files | 2025-12-18 |
| E226007163R18 - KOMET Root Canal Files | 2025-12-18 |
| E226007164R18 - KOMET Root Canal Files | 2025-12-18 |
| E226007243R18 - KOMET Root Canal Files | 2025-12-18 |