Patella Components 15-2521/35

GUDID 04026575198009

centric, 1-Peg

WALDEMAR LINK GmbH & Co. KG

Polyethylene patella prosthesis
Primary Device ID04026575198009
NIH Device Record Key3fd6dd33-8671-4dfa-bf63-1b9d3d9947e9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatella Components
Version Model Number15-2521/35
Catalog Number15-2521/35
Company DUNS315675488
Company NameWALDEMAR LINK GmbH & Co. KG
Device Count1
DM Exempttrue
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
GS104026575198009 [Primary]

FDA Product Code

KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-05
Device Publish Date2015-11-01

On-Brand Devices [Patella Components]

040265753940433-Peg, Size 4
040265753940363-Peg, Size 3
040265753940293-Peg, Size 2
040265753940123-Peg, Size 1
04026575198009centric, 1-Peg
04026575045433centric, 1-Peg
04026575045426centric, 1-Peg

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