Monoblock Tibial Trial UC Insert

GUDID 09348215043254

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215043254
NIH Device Record Keybb556e83-c6d7-4328-b63d-4083393e3b01
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonoblock Tibial Trial UC Insert
Version Model Number122-10-0825
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
GS109348215043254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215043254]

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 [Monoblock Tibial Trial UC Insert]

09348215043681122-10-0886
09348215043674122-10-0885
09348215043667122-10-0884
09348215043650122-10-0883
09348215043643122-10-0882
09348215043636122-10-0881
09348215043629122-10-0880
09348215043612122-10-0876
09348215043605122-10-0875
09348215043599122-10-0874
09348215043582122-10-0873
09348215043575122-10-0872
09348215043568122-10-0871
09348215043551122-10-0870
09348215043544122-10-0866
09348215043537122-10-0865
09348215043520122-10-0864
09348215043513122-10-0863
09348215043506122-10-0862
09348215043490122-10-0861
09348215043483122-10-0860
09348215043476122-10-0856
09348215043469122-10-0855
09348215043452122-10-0854
09348215043445122-10-0853
09348215043438122-10-0852
09348215043421122-10-0851
09348215043414122-10-0850
09348215043407122-10-0846
09348215043391122-10-0845
09348215043384122-10-0844
09348215043377122-10-0843
09348215043360122-10-0842
09348215043353122-10-0841
09348215043346122-10-0840
09348215043339122-10-0836
09348215043322122-10-0835
09348215043315122-10-0834
09348215043308122-10-0833
09348215043292122-10-0832
09348215043285122-10-0831
09348215043278122-10-0830
09348215043261122-10-0826
09348215043254122-10-0825
09348215043247122-10-0824
09348215043230122-10-0823
09348215043223122-10-0822
09348215043216122-10-0821
09348215043209122-10-0820
09348215043193122-10-0816

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