World Knee Vit-E PS Poly Insert

GUDID 09348215090913

SIGNATURE ORTHOPAEDICS PTY LTD

Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert
Primary Device ID09348215090913
NIH Device Record Key710ae67f-9520-42c5-b7de-09c20edb6e9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee Vit-E PS Poly Insert
Version Model Number121-20-7747
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
GS109348215090913 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

On-Brand Devices [World Knee Vit-E PS Poly Insert]

09348215091101121-20-7948
09348215091095121-20-7947
09348215091088121-20-7946
09348215091071121-20-7945
09348215091064121-20-7944
09348215091057121-20-7943
09348215091040121-20-7942
09348215091033121-20-7941
09348215091026121-20-7940
09348215091019121-20-7848
09348215091002121-20-7847
09348215090999121-20-7846
09348215090982121-20-7845
09348215090975121-20-7844
09348215090968121-20-7843
09348215090951121-20-7842
09348215090944121-20-7841
09348215090937121-20-7840
09348215090920121-20-7748
09348215090913121-20-7747
09348215090906121-20-7746
09348215090890121-20-7745
09348215090883121-20-7744
09348215090876121-20-7743
09348215090869121-20-7742
09348215090852121-20-7741
09348215090845121-20-7740
09348215090838121-20-7648
09348215090821121-20-7647
09348215090814121-20-7646
09348215090807121-20-7645
09348215090791121-20-7644
09348215090784121-20-7643
09348215090777121-20-7642
09348215090760121-20-7641
09348215090753121-20-7640
09348215090746121-20-7548
09348215090739121-20-7547
09348215090722121-20-7546
09348215090715121-20-7545
09348215090708121-20-7544
09348215090692121-20-7543
09348215090685121-20-7542
09348215090678121-20-7541
09348215090661121-20-7540
09348215090654121-20-7448
09348215090647121-20-7447
09348215090630121-20-7446
09348215090623121-20-7445
09348215090616121-20-7444

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