| Primary Device ID | 00850040139792 |
| NIH Device Record Key | 761b43c9-3126-4e19-8c3a-921aca5d355f |
| Commercial Distribution Discontinuation | 2024-09-23 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Disposable Impactor |
| Version Model Number | SR19-3000 |
| 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 | 00850040139792 [Primary] |
| MRW | System, Facet Screw Spinal Device |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-01 |
| Device Publish Date | 2024-09-23 |
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| 00858406007785 - Narrow Rectangular Access Tip Adapter | 2025-03-24 |
| 00858406007846 - PLAT Tip Adapter Medium | 2025-03-24 |