AccessGUDID - DEVICE: BIO-MODULAR / BI-POLAR SHOULDER (00880304212411)

GUDID

Device Identifier (DI) Information

Brand Name: BIO-MODULAR / BI-POLAR SHOULDER
Version or Model: 113147
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 113147
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304212411
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?
33712	Bipolar partial shoulder prosthesis	A sterile implantable artificial substitute for the humeral component of a shoulder joint typically replaced due to injury (e.g., fracture). It includes humeral head and stem components and a humeral head bipolar component (device that articulates with the humeral head prosthesis on one surface and the natural glenoid fossa on the other), typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWT	PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
MJT	PROSTHESIS, SHOULDER, HUMERAL (BIPOLAR HEMI-SHOULDER) METAL/POLYMER, CEMENTED OR UNCEMENTED
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
MBF	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030710	000
K960363	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: -4MM HEIGHT

Device Record Status

Public Device Record Key: dd930476-6f25-4c65-a8fd-38ee8edec505
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: October 24, 2015