Encore Hip Stem

GUDID 09348215082918

SIGNATURE ORTHOPAEDICS PTY LTD

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Primary Device ID09348215082918
NIH Device Record Key50851e9e-bb1b-49c9-afe2-ea5251d36928
Commercial Distribution StatusIn Commercial Distribution
Brand NameEncore Hip Stem
Version Model Number111-45-0512
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
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 Datetrue
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
GS109348215082918 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-13
Device Publish Date2021-10-05

On-Brand Devices [Encore Hip Stem]

09348215083052111-45-1213
09348215083045111-45-1113
09348215083038111-45-1013
09348215083021111-45-0913
09348215083014111-45-0813
09348215083007111-45-0713
09348215082994111-45-0613
09348215082987111-45-1212
09348215082970111-45-1112
09348215082963111-45-1012
09348215082956111-45-0912
09348215082949111-45-0812
09348215082932111-45-0712
09348215082925111-45-0612
09348215082918111-45-0512
09348215082901111-45-0412
09348215082895111-45-0312
09348215082888111-45-0212
09348215082871111-45-0112
09348215082864111-45-0012
09348215082857111-45-1211
09348215082840111-45-1111
09348215082833111-45-1011
09348215082826111-45-0911
09348215082819111-45-0811
09348215082802111-45-0711
09348215082796111-45-0611
09348215082789111-45-0511
09348215082772111-45-0411
09348215082765111-45-0311
09348215082758111-45-0211
09348215082741111-45-0111
09348215082734111-45-0011

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