EasyTech Anatomical

GUDID 03701037320426

MONOBLOC CUTTING GUIDE WITH GUIDE

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID03701037320426
NIH Device Record Keyb32a40d4-5401-4a20-b808-cb068b4bb01f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasyTech Anatomical
Version Model Number910-0130-CM1
Company DUNS263076196
Company NameFX SOLUTIONS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103701037320426 [Primary]

FDA Product Code

PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-11
Device Publish Date2025-03-03

Devices Manufactured by FX SOLUTIONS

03701037320426 - EasyTech Anatomical2025-03-11MONOBLOC CUTTING GUIDE WITH GUIDE
03701037320426 - EasyTech Anatomical2025-03-11 MONOBLOC CUTTING GUIDE WITH GUIDE
03701037320532 - Humelock II2025-03-11 HUMELOCK II TRAY
03701037321010 - FX V1352025-02-28 XS GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR TILT
03701037321027 - FX V1352025-02-28 M GLENOID K-WIRE GUIDE +TEMPLATE W/5° SUPERIOR TILT
03701037321034 - FX V1352025-02-28 XS GLENOID K-WIRE GUIDE +TEMPLATE W/10° SUPERIOR TILT
03701037321041 - FX V1352025-02-28 M GLENOID K-WIRE GUIDE +TEMPLATE W/10° SUPERIOR TILT
03701037321058 - FX V1352025-02-28 XS GLENOID K-WIRE GUIDE +TEMPLATE W/5° POSTERIOR TILT
03701037321065 - FX V1352025-02-28 M GLENOID K-WIRE GUIDE +TEMPLATE W/5° POSTERIOR TILT

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