World Knee Vit-E PS All Poly Tibia

GUDID 09348215088835

SIGNATURE ORTHOPAEDICS PTY LTD

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID09348215088835
NIH Device Record Keyf5d391f2-8039-437e-af6d-9143268bc493
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee Vit-E PS All Poly Tibia
Version Model Number121-20-6346
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
GS109348215088835 [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 Date2022-05-03
Device Publish Date2022-04-25

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

09348215089191121-20-6946
09348215089184121-20-6944
09348215089177121-20-6942
09348215089160121-20-6940
09348215089139121-20-6846
09348215089122121-20-6844
09348215089115121-20-6842
09348215089108121-20-6840
09348215089078121-20-6746
09348215089061121-20-6744
09348215089054121-20-6742
09348215089047121-20-6740
09348215089016121-20-6646
09348215089009121-20-6644
09348215088996121-20-6642
09348215088989121-20-6640
09348215088958121-20-6546
09348215088941121-20-6544
09348215088934121-20-6542
09348215088927121-20-6540
09348215088897121-20-6446
09348215088880121-20-6444
09348215088873121-20-6442
09348215088866121-20-6440
09348215088835121-20-6346
09348215088828121-20-6344
09348215088811121-20-6342
09348215088804121-20-6340
09348215088774121-20-6246
09348215088767121-20-6244
09348215088750121-20-6242
09348215088743121-20-6240
09348215088712121-20-6146
09348215088705121-20-6144
09348215088699121-20-6142
09348215088682121-20-6140
09348215089214121-20-6949
09348215089207121-20-6948
09348215089153121-20-6849
09348215089146121-20-6848
09348215089092121-20-6749
09348215089085121-20-6748
09348215089030121-20-6649
09348215089023121-20-6648
09348215088972121-20-6549
09348215088965121-20-6548
09348215088910121-20-6449
09348215088903121-20-6448
09348215088859121-20-6349
09348215088842121-20-6348

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