AccessGUDID - DEVICE: FX V135 Shoulder Prosthesis (03701037315293)

GUDID

Device Identifier (DI) Information

Brand Name: FX V135 Shoulder Prosthesis
Version or Model: 202-0809
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: FX SOLUTIONS

Primary DI Number: 03701037315293
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 263076196 *Terms of Use

Device Description: FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +9

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48092	Polyethylene reverse shoulder prosthesis cup	A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PHX	Shoulder Prosthesis, Reverse Configuration
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213117	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e14bb7c-9aee-4116-8faf-25285b042f22
Public Version Date: July 01, 2026
Public Version Number: 2
DI Record Publish Date: January 22, 2024