AccessGUDID - DEVICE: G7 OSSEOTI ACETABULAR SHELL (00880304544390)

GUDID

Device Identifier (DI) Information

Brand Name: G7 OSSEOTI ACETABULAR SHELL
Version or Model: 110010264
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110010264
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304544390
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?
43167	Acetabular shell	An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OQI	Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
PBI	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
OQH	Hip, semi-constrained, cemented, metal/polymer + additive, cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140669	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: 52MM SHELL SIZE E LINER SIZE

Device Record Status

Public Device Record Key: e46cbae5-338e-4fb0-96fd-132cb12c21d1
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: November 02, 2015