AccessGUDID - DEVICE: BIO-MOORE ENDO II HIP SYSTEM (00880304221802)

GUDID

Device Identifier (DI) Information

Brand Name: BIO-MOORE ENDO II HIP SYSTEM
Version or Model: 12-139022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12-139022
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304221802
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?
33695	Bipolar femoral head outer component, hemiarthroplasty	An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWL	Prosthesis, hip, hemi-, femoral, metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984028	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: 49 MM

Device Record Status

Public Device Record Key: 1d902524-65a1-4810-a3ac-0b7e48419aac
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: October 24, 2015