| Primary Device ID | 10810563022749 |
| NIH Device Record Key | fe2ddc19-3afc-412c-b06d-692396c9ab09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OmniBone Bone Biopsy Kit with 11 Gauge 158mm length |
| Version Model Number | OMB 11/15 |
| Company DUNS | 009120817 |
| Company Name | VARIAN MEDICAL SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810563022742 [Primary] |
| GS1 | 10810563022749 [Package] Contains: 00810563022742 Package: [5 Units] In Commercial Distribution |
| KNW | Instrument, biopsy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-26 |
| Device Publish Date | 2025-09-18 |
| 10810563022725 - OmniBone Bone Biopsy Kit with 11 Gauge 68mm length | 2025-09-26 |
| 10810563022732 - OmniBone Bone Biopsy Kit with 11 Gauge 108mm length | 2025-09-26 |
| 10810563022749 - OmniBone Bone Biopsy Kit with 11 Gauge 158mm length | 2025-09-26 |
| 10810563022749 - OmniBone Bone Biopsy Kit with 11 Gauge 158mm length | 2025-09-26 |
| 10810563022824 - OmniBone Bone Marrow Biopsy kit with 11 Gauge 100mm | 2025-09-26 |
| 10810563023036 - OmniBone Bone Marrow Biopsy kit with 11 Gauge 150mm | 2025-09-26 |
| 00810563023046 - OmniBone Power Driver | 2025-09-26 |
| 00810563023053 - OmniBone Charger | 2025-09-26 |
| 00810563023060 - OmniBone Power Driver and Charger | 2025-09-26 |