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 |