| Primary Device ID | 00858406007037 |
| NIH Device Record Key | 095c7e06-07cf-4235-bcd6-9bc15c2f2cd4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Graftgun Universal Graft Delivery System - Narrow Tip Adapter |
| Version Model Number | GG-NTA-01 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00858406007037 [Primary] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00858406007037]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-04-15 |
| Device Publish Date | 2019-01-24 |
| 00081013188039 - ION AO Coupling Cannulated Handle | 2026-03-17 SR12- ION Facet Screw System |
| 00810131880330 - T-Handle 3/16" Connection | 2026-03-17 |
| 00810131881252 - 6.5/7.0 Drill Bit | 2026-03-17 SR12- ION Facet Screw System |
| 00810131881429 - OsteoFlo HydroFiber - 1cc Labeled | 2026-03-17 |
| 00810131881436 - OsteoFlo HydroFiber - 3cc Labeled | 2026-03-17 |
| 00810131881443 - OsteoFlo HydroFiber - 6cc Labeled | 2026-03-17 |
| 00810131881450 - OsteoFlo HydroFiber - 12cc Labeled | 2026-03-17 |
| 00810131881726 - ION Facet Screw System | 2026-03-17 ION Facet Screw - 7.0 x 10mm |