| Primary Device ID | 00858406007099 |
| NIH Device Record Key | fef0c289-8f20-41f0-a8cf-a465019957ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Graftgun Universal Graft Delivery System -Long Narrow Tip Adapter |
| Version Model Number | GG-NTA-02 |
| 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 | 00858406007099 [Primary] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00858406007099]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-22 |
| Device Publish Date | 2019-04-13 |
| 00858406007075 - GraftRasp Teeth and Set Screw - Curved | 2022-06-10 |
| 00858406007563 - GraftRasp Teeth and Set Screw- Straight | 2022-06-10 |
| 00858406007600 - Flexible Pusher Tip and Set Screw | 2022-06-10 |
| 00858406007709 - GraftRasp Teeth and Set Screw - Bladed | 2022-06-10 |
| 00850040139006 - ION Facet Screw System | 2022-04-28 ION Facet Screw - 6.0 x 10mm |
| 00850040139013 - ION Facet Screw System | 2022-04-28 ION Facet Screw - 6.0 x 15mm |
| 00850040139020 - ION Facet Screw System | 2022-04-28 ION Facet Screw - 6.0 x 25mm |
| 00850040139037 - ION Facet Screw System | 2022-04-28 ION Facet Screw - 6.0 x 35mm |