AccessGUDID - DEVICE: G7 PROVISIONAL HIGH WALL LINER (00880304551770)

GUDID

Device Identifier (DI) Information

Brand Name: G7 PROVISIONAL HIGH WALL LINER
Version or Model: 010002674
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 010002674
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00880304551770
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:	No
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?
58480	Acetabulum prosthesis trial, prefabricated, reusable	A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
OQI	Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
OQH	Hip, semi-constrained, cemented, metal/polymer + additive, cemented
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
PBI	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
LWZ	TISSUE GRAFT OF LESS THAN 6MM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121874	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 40MM I

Device Record Status

Public Device Record Key: b4f9566b-05ec-4dbe-8c0f-5b73c69d7a00
Public Version Date: May 30, 2025
Public Version Number: 8
DI Record Publish Date: September 23, 2016