| Primary Device ID | 00818345029071 |
| NIH Device Record Key | 52dda546-b36b-4e25-b1f3-99909d690196 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xenix Medical Sacroiliac Fixation System |
| Version Model Number | SS1-A4-000030 |
| Company DUNS | 080386764 |
| Company Name | Ht Medical, 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 | false |
| 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 |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com | |
| Phone | 888-594-8633 |
| cs@xenixmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818345029071 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
[00818345029071]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-04 |
| Device Publish Date | 2023-08-25 |
| 00818345029095 | Nav Awl Tip-Tap, 5mm |
| 00818345029088 | Graft Luer Adapter |
| 00818345029071 | Graft Plunger |
| 00818345029064 | Graft Funnel |
| 00818345029040 | SI Implant Inserter |
| 00818345029033 | SI Implant Nav Inserter |
| 00818345029026 | Nav SI Tap 12mm |
| 00818345029019 | Nav SI Tap 11mm |
| 00818345029002 | Nav SI Tap 10mm |
| 00818345028999 | Nav SI Tap 9mm |
| 00818345028968 | 11mm SI Tap |
| 00818345028944 | 9mm SI Tap |
| 00818345028616 | Nav Awl Tip-Tap, 7mm |
| 00818345028449 | SI Implant, 12mm x 115mm |
| 00818345028432 | SI Implant, 12mm x 110mm |
| 00818345028425 | SI Implant, 12mm x 105mm |
| 00818345028418 | SI Implant, 12mm x 100mm |
| 00818345028401 | SI Implant, 12mm x 95mm |
| 00818345028395 | SI Implant, 12mm x 90mm |
| 00818345028388 | SI Implant, 12mm x 85mm |
| 00818345028371 | SI Implant, 12mm x 80mm |
| 00818345028364 | SI Implant, 12mm x 75mm |
| 00818345028357 | SI Implant, 12mm x 70mm |
| 00818345028340 | SI Implant, 12mm x 65mm |
| 00818345028333 | SI Implant, 12mm x 60mm |
| 00818345028326 | SI Implant, 12mm x 55mm |
| 00818345028319 | SI Implant, 12mm x 50mm |
| 00818345028302 | SI Implant, 12mm x 45mm |
| 00818345028296 | SI Implant, 12mm x 40mm |
| 00818345028289 | SI Implant, 12mm x 35mm |
| 00818345028272 | SI Implant, 12mm x 30mm |
| 00818345028265 | SI Implant, 10.5mm x 115mm |
| 00818345028258 | SI Implant, 10.5mm x 110mm |
| 00818345028241 | SI Implant, 10.5mm x 105mm |
| 00818345028234 | SI Implant, 10.5mm x 100mm |
| 00818345028227 | SI Implant, 10.5mm x 95mm |
| 00818345028210 | SI Implant, 10.5mm x 90mm |
| 00818345028203 | SI Implant, 10.5mm x 85mm |
| 00818345028173 | 1/4" Sq to Tri-Flat Adapter |
| 00818345028166 | SI Implant, 10.5mm x 80mm |
| 00818345028159 | SI Implant, 10.5mm x 75mm |
| 00818345028142 | SI Implant, 10.5mm x 70mm |
| 00818345028135 | SI Implant, 10.5mm x 65mm |
| 00818345028128 | SI Implant, 10.5mm x 60mm |
| 00818345028111 | SI Implant, 10.5mm x 55mm |
| 00818345028104 | SI Implant, 10.5mm x 50mm |
| 00818345028098 | SI Implant, 10.5mm x 45mm |
| 00818345028081 | SI Implant, 10.5mm x 40mm |
| 00818345028074 | SI Implant, 10.5mm x 35mm |
| 00818345028067 | SI Implant, 10.5mm x 30mm |