AccessGUDID - DEVICE: Comprehensive Reverse Shoulder (00880304475786)

GUDID

Device Identifier (DI) Information

Brand Name: Comprehensive Reverse Shoulder
Version or Model: 115316
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 115316
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304475786
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?
48093	Reverse shoulder prosthesis head	A sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.	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
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: 36MM Ø OF CURV +6MM OFFSET

Device Record Status

Public Device Record Key: 7e979796-af99-4731-bd70-87d170c19cea
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: October 24, 2015