AccessGUDID - DEVICE: Comprehensive Reverse Shoulder (00880304543157)

GUDID

Device Identifier (DI) Information

Brand Name: Comprehensive Reverse Shoulder
Version or Model: EP-115393
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EP-115393
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304543157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: No description.

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
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PAO	prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
PHX	shoulder prosthesis, reverse configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080642	000
K113121	000
K193373	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
Device Size Text, specify: 44MM Ø 36MM Ø OF CURV STANDARD

Device Record Status

Public Device Record Key: 4e422250-ad17-42c0-84fe-42ba22b1483c
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: October 24, 2015