Primary Device ID | 03701037320426 |
NIH Device Record Key | b32a40d4-5401-4a20-b808-cb068b4bb01f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EasyTech Anatomical |
Version Model Number | 910-0130-CM1 |
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 | 03701037320426 [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 |
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
[03701037320426]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-11 |
Device Publish Date | 2025-03-03 |
03701037320426 - EasyTech Anatomical | 2025-03-11MONOBLOC CUTTING GUIDE WITH GUIDE |
03701037320426 - EasyTech Anatomical | 2025-03-11 MONOBLOC CUTTING GUIDE WITH GUIDE |
03701037320532 - Humelock II | 2025-03-11 HUMELOCK II TRAY |
03701037321010 - FX V135 | 2025-02-28 XS GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR TILT |
03701037321027 - FX V135 | 2025-02-28 M GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR TILT |
03701037321034 - FX V135 | 2025-02-28 XS GLENOID K-WIRE GUIDE +TEMPLATE W/10° SUPERIOR TILT |
03701037321041 - FX V135 | 2025-02-28 M GLENOID K-WIRE GUIDE +TEMPLATE W/10° SUPERIOR TILT |
03701037321058 - FX V135 | 2025-02-28 XS GLENOID K-WIRE GUIDE +TEMPLATE W/5° POSTERIOR TILT |
03701037321065 - FX V135 | 2025-02-28 M GLENOID K-WIRE GUIDE +TEMPLATE W/5° POSTERIOR TILT |