AccessGUDID - DEVICE: DISCOVERY-MOSAIC ELBOW SYSTEM (00880304215672)

GUDID

Device Identifier (DI) Information

Brand Name: DISCOVERY-MOSAIC ELBOW SYSTEM
Version or Model: 114890
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 114890
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304215672
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?
33702	Uncoated elbow humerus prosthesis	A sterile implantable device designed to replace the distal humerus as part of an elbow joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
JDC	PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020045	000
K033280	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: STANDARD LENGTH

Device Record Status

Public Device Record Key: 884d93ec-8cf9-4ff6-926e-095b7f82fd60
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: October 24, 2015