| Primary Device ID | 00810131881030 |
| NIH Device Record Key | ce4f4ee8-795d-4c10-9758-36dd808e9c78 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BMAC Diamond Needle Kit - Two Pack Copy |
| Version Model Number | SR07-1303 |
| 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 | 00810131881030 [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 | 2025-01-08 |
| Device Publish Date | 2024-12-31 |
| 00810131880545 - Global Tip Adapter - Long | 2025-03-24 |
| 00810131881191 - Global Tip Adapter - Narrow | 2025-03-24 |
| 00810131881207 - Bullet Global Tip Adapter | 2025-03-24 |
| 00858406007150 - Bullet Tip Adapter | 2025-03-24 |
| 00858406007167 - Global Tip Adapter | 2025-03-24 |
| 00858406007730 - Rectangular Access Tip Adapter | 2025-03-24 |
| 00858406007785 - Narrow Rectangular Access Tip Adapter | 2025-03-24 |
| 00858406007846 - PLAT Tip Adapter Medium | 2025-03-24 |