AccessGUDID - DEVICE: Comprehensive Shoulder System (00880304531048)

GUDID

Device Identifier (DI) Information

Brand Name: Comprehensive Shoulder System
Version or Model: 118000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 118000
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304531048
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?
48091	Reverse shoulder prosthesis base plate	A sterile component of a reverse shoulder prosthesis that consists of a metal plate [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] intended to be firmly attached to the scapula with screws. It is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PHX	shoulder prosthesis, reverse configuration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080642	000
K120121	000
K193373	000
K202232	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: 232cb470-eb81-433a-b52f-85267a48db08
Public Version Date: April 07, 2021
Public Version Number: 5
DI Record Publish Date: October 24, 2015