Primary Device ID | 03701037321010 |
NIH Device Record Key | b64c3172-6b67-46ae-9112-9e188e0d798b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FX V135 |
Version Model Number | 911-2051 |
Catalog Number | 911-2051 |
Company DUNS | 263076196 |
Company Name | FX SOLUTIONS |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
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 | 03701037321010 [Primary] |
PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
[03701037321010]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-02-28 |
Device Publish Date | 2025-02-20 |
03701037321102 | M GLENOID K-WIRE GUIDE +TEMPLATE W/10° ANTERIOR TILT |
03701037321096 | M GLENOID K-WIRE GUIDE +TEMPLATE W/5° ANTERIOR TILT |
03701037321089 | 911-2113 |
03701037321072 | XS GLENOID K-WIRE GUIDE +TEMPLATE W/10° POSTERIOR TILT |
03701037321065 | M GLENOID K-WIRE GUIDE +TEMPLATE W/5° POSTERIOR TILT |
03701037321058 | XS GLENOID K-WIRE GUIDE +TEMPLATE W/5° POSTERIOR TILT |
03701037321041 | M GLENOID K-WIRE GUIDE +TEMPLATE W/10° SUPERIOR TILT |
03701037321034 | XS GLENOID K-WIRE GUIDE +TEMPLATE W/10° SUPERIOR TILT |
03701037321027 | M GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR TILT |
03701037321010 | XS GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR TILT |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FX V135 97481531 not registered Live/Pending |
FX SOLUTIONS 2022-06-29 |