| Primary Device ID | 00810131881047 |
| NIH Device Record Key | 37b4a9ab-d17d-42f0-91c5-eeeb1637d1c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BMAC Bevel Needle Assembly |
| Version Model Number | SR07-1400 |
| Company DUNS | 004095409 |
| Company Name | SURGENTEC, LLC |
| 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 | 00810131881047 [Primary] |
| PDQ | Neurosurgical Nerve Locator |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-13 |
| Device Publish Date | 2025-01-03 |
| 00858406007358 - Decortication Rasp - Fixed Curved | 2025-02-04 |
| 00810131880798 - Spinous Process Plate, 8mm | 2025-01-13 |
| 00810131880804 - Spinous Process Plate, 10mm | 2025-01-13 |
| 00810131880811 - Spinous Process Plate, 12mm | 2025-01-13 |
| 00810131880828 - Spinous Process Plate, 14mm | 2025-01-13 |
| 00810131880835 - Spinous Process Plate, 16mm | 2025-01-13 |
| 00810131881047 - BMAC Bevel Needle Assembly | 2025-01-13 |
| 00810131881047 - BMAC Bevel Needle Assembly | 2025-01-13 |
| 00810131881054 - BMAC Bevel Needle Pouched | 2025-01-13 |