FX V135® Shoulder Prothesis

GUDID 03701037320525

RESURFACING GLENOID REAMER Ø54mm

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID03701037320525
NIH Device Record Key57279e75-c924-4db4-90cd-0c9fae221bd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameFX V135® Shoulder Prothesis
Version Model Number907-0054
Company DUNS263076196
Company NameFX SOLUTIONS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103701037320525 [Primary]

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-13
Device Publish Date2024-08-05

On-Brand Devices [FX V135® Shoulder Prothesis]

03701037320518RESURFACING GLENOID REAMER Ø52mm
03701037320525RESURFACING GLENOID REAMER Ø54mm

Trademark Results [FX V135]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FX V135
FX V135
97481531 not registered Live/Pending
FX SOLUTIONS
2022-06-29

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