Patella Components 318-401/31

GUDID 04026575394036

3-Peg, Size 3

WALDEMAR LINK GmbH & Co. KG

Polyethylene patella prosthesis
Primary Device ID04026575394036
NIH Device Record Key82df189d-84c7-4695-95e0-b638cf76ad9d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatella Components
Version Model Number318-401/31
Catalog Number318-401/31
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
GS104026575394036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
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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