World Knee PS TiN Femur Right

GUDID 09348215106010

SIGNATURE ORTHOPAEDICS PTY LTD

Coated knee femur prosthesis
Primary Device ID09348215106010
NIH Device Record Keyc07d25cc-07f2-4a4f-a059-8f4e85caecda
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld Knee PS TiN Femur Right
Version Model Number121-20-4802
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
GS109348215106010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-08
Device Publish Date2023-02-28

On-Brand Devices [World Knee PS TiN Femur Right]

09348215106072121-20-4902
09348215106010121-20-4802
09348215105952121-20-4702
09348215105891121-20-4602
09348215105839121-20-4502
09348215105778121-20-4402
09348215105716121-20-4302
09348215105655121-20-4202
09348215105594121-20-4102

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