TLC Uni Knee Meniscal Insert

GUDID 09348215077310

SIGNATURE ORTHOPAEDICS PTY LTD

Unicondylar knee prosthesis
Primary Device ID09348215077310
NIH Device Record Key97b23990-2932-4147-b6b8-2c073c600b0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLC Uni Knee Meniscal Insert
Version Model Number121-21-2101
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
GS109348215077310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-08
Device Publish Date2022-06-30

On-Brand Devices [TLC Uni Knee Meniscal Insert]

09348215077723121-21-2611
09348215077709121-21-2601
09348215077686121-21-2691
09348215077648121-21-2511
09348215077624121-21-2501
09348215077600121-21-2591
09348215077563121-21-2411
09348215077549121-21-2401
09348215077525121-21-2491
09348215077488121-21-2311
09348215077464121-21-2301
09348215077440121-21-2391
09348215077402121-21-2211
09348215077389121-21-2201
09348215077365121-21-2291
09348215077334121-21-2111
09348215077310121-21-2101
09348215077297121-21-2191

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