| Primary Device ID | 03701037320525 |
| NIH Device Record Key | 57279e75-c924-4db4-90cd-0c9fae221bd5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FX V135® Shoulder Prothesis |
| Version Model Number | 907-0054 |
| Company DUNS | 263076196 |
| Company Name | FX SOLUTIONS |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701037320525 [Primary] |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
[03701037320525]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-13 |
| Device Publish Date | 2024-08-05 |
| 03701037320518 | RESURFACING GLENOID REAMER Ø52mm |
| 03701037320525 | RESURFACING GLENOID REAMER Ø54mm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FX V135 97481531 not registered Live/Pending |
FX SOLUTIONS 2022-06-29 |