Modular Stem, 15-8522/57

GUDID 04026575383849

Modular Stem,

WALDEMAR LINK GmbH & Co. KG

Knee femur stem prosthesis
Primary Device ID04026575383849
NIH Device Record Key0be4ba48-67cd-4e5b-8f0e-418391c37008
Commercial Distribution StatusIn Commercial Distribution
Brand NameModular Stem,
Version Model Number15-8522/57
Catalog Number15-8522/57
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
GS104026575383849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-20
Device Publish Date2015-11-01

On-Brand Devices [Modular Stem,]

04026575383894Modular Stem,
04026575383887Modular Stem,
04026575383870Modular Stem,
04026575383863Modular Stem,
04026575383856Modular Stem,
04026575383849Modular Stem,
04026575383832Modular Stem,
04026575383825Modular Stem,
04026575383818Modular Stem,
04026575383801Modular Stem,
04026575383795Modular Stem,
04026575383788Modular Stem,
04026575383771Modular Stem,
04026575381784Modular Stem,
04026575381777Modular Stem,
04026575381746Modular Stem,

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