Tibial Trial UC Insert

GUDID 09348215043001

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215043001
NIH Device Record Key8be19d17-d58e-47aa-9c96-d1a6728e4465
Commercial Distribution StatusIn Commercial Distribution
Brand NameTibial Trial UC Insert
Version Model Number122-10-0580
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
GS109348215043001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215043001]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-14
Device Publish Date2018-10-05

On-Brand Devices [Tibial Trial UC Insert]

09348215043056122-10-0585
09348215043049122-10-0584
09348215043032122-10-0583
09348215043025122-10-0582
09348215043018122-10-0581
09348215043001122-10-0580
09348215042998122-10-0579

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