World Knee Vit-E UC All Poly Tibia

GUDID 09348215089801

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID09348215089801
NIH Device Record Keyc2f92a43-e4b7-4449-97f4-750f388115d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee Vit-E UC All Poly Tibia
Version Model Number121-20-6168
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
GS109348215089801 [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 Date2023-08-02
Device Publish Date2023-07-25

On-Brand Devices [World Knee Vit-E UC All Poly Tibia]

09348215090272121-20-6966
09348215090265121-20-6964
09348215090258121-20-6962
09348215090241121-20-6960
09348215090210121-20-6866
09348215090197121-20-6862
09348215090180121-20-6860
09348215090159121-20-6766
09348215090142121-20-6764
09348215090135121-20-6762
09348215090128121-20-6760
09348215090098121-20-6666
09348215090081121-20-6664
09348215090074121-20-6662
09348215090067121-20-6660
09348215090036121-20-6566
09348215090029121-20-6564
09348215090012121-20-6562
09348215090005121-20-6560
09348215089979121-20-6466
09348215089962121-20-6464
09348215089955121-20-6462
09348215089948121-20-6460
09348215089917121-20-6366
09348215089900121-20-6364
09348215089894121-20-6362
09348215089887121-20-6360
09348215089856121-20-6266
09348215089849121-20-6264
09348215089832121-20-6262
09348215089825121-20-6260
09348215089795121-20-6166
09348215089788121-20-6164
09348215089771121-20-6162
09348215089764121-20-6160
09348215090203121-20-6864
09348215090296121-20-6969
09348215090289121-20-6968
09348215090234121-20-6869
09348215090227121-20-6868
09348215090173121-20-6769
09348215090166121-20-6768
09348215090111121-20-6669
09348215090104121-20-6668
09348215090050121-20-6569
09348215090043121-20-6568
09348215089993121-20-6469
09348215089986121-20-6468
09348215089931121-20-6369
09348215089924121-20-6368

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