Patella Trial 32x8

GUDID 09348215056797

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215056797
NIH Device Record Key3c1b6acf-6364-4afb-8813-6580ddb39a3c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatella Trial 32x8
Version Model Number122-102-248
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215056797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215056797]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-12
Device Publish Date2019-11-04

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215135362 - World Cup Liner – Neutral Lateralised2024-12-11
09348215135379 - World Cup Liner – Neutral Lateralised2024-12-11
09348215135386 - World Cup Liner – Neutral Lateralised2024-12-11
09348215135393 - World Cup Liner – Neutral Lateralised2024-12-11
09348215135409 - World Cup Liner – Neutral Lateralised2024-12-11
09348215135416 - World Cup Liner – Neutral Lateralised2024-12-11
09348215135423 - World Cup Liner – Neutral Lateralised2024-12-11
09348215135430 - World Cup Liner – Neutral Lateralised2024-12-11

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