GMK

GUDID 07630971261006

Patella resurfacing # 4 E-Cross

Medacta International SA

Polyethylene patella prosthesis
Primary Device ID07630971261006
NIH Device Record Keyd59b8021-653b-4261-8a41-c59ab372bcc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMK
Version Model Number02.12.E004RP
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630971261006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-08
Device Publish Date2020-09-30

On-Brand Devices [GMK ]

07630971261006Patella resurfacing # 4 E-Cross
07630971260993Patella resurfacing # 3 E-Cross
07630971260986Patella resurfacing # 2 E-Cross
07630971260979Patella resurfacing # 1 E-Cross

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