GMK Uni

Basic Information

• Brand Name: GMK Uni
• Primary DI: 07630030824326
• Version / Model: 02.08.IF4.09.RMLL
• Company Name: Medacta International SA
• Labeler DUNS: 488227125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-25
• Public Version: 1
• Public Version Date: 2021-11-02
• Public Version Status: New
• Public Device Record Key: 132ddbd0-7cc4-4317-b679-a4145dbbc7e9

Device Description

Fixed tibial insert #4 11mm RM-LL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	888.3520	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48070	Unicondylar knee insert	A sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630030824326	GS1