| Primary Device ID | 05055662968392 |
| NIH Device Record Key | 907abe5a-766e-44d6-8742-c9de5c41b3af |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHO SOLUTIONS ULTOS/VOLITION PLATING SYSTEM |
| Version Model Number | OS328001-NS |
| Catalog Number | OS328001-NS |
| Company DUNS | 218648211 |
| Company Name | ORTHO SOLUTIONS HOLDINGS LIMITED |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com | |
| Phone | +441621843599 |
| quality@orthosol.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055662968392 [Primary] |
| HTJ | Gauge, Depth |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
[05055662968392]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-10 |
| Device Publish Date | 2022-09-30 |
| 05055662970081 - Volition™ Plating System | 2024-09-10 MTPJ PLATE EXTRA SHORT LEFT |
| 05055662970104 - Volition™ Plating System | 2024-09-10 MTPJ PLATE EXTRA SHORT RIGHT |
| 05055662970128 - Volition™ Plating System | 2024-09-10 TIBIA PLATE ANTERIOR LARGE LEFT |
| 05055662970142 - Volition™ Plating System | 2024-09-10 TIBIA PLATE ANTERIOR LARGE RIGHT |
| 05055662970166 - Volition™ Plating System | 2024-09-10 TIBIA PLATE ANTERIOR SMALL LEFT |
| 05055662970180 - Volition™ Plating System | 2024-09-10 TIBIA PLATE ANTERIOR SMALL RIGHT |
| 05055662969658 - COGNiTiON™ Staple System | 2024-04-09 COGNiTiON 2 LEG STAPLE 10MM X10MM |
| 05055662969665 - COGNiTiON™ Staple System | 2024-04-09 COGNiTiON 2 LEG STAPLE 15MM X 15MM |