Monoblock Tibial Trial PS Insert

GUDID 09348215042295

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215042295
NIH Device Record Key5c48f813-d10f-4feb-ae79-054c07575224
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonoblock Tibial Trial PS Insert
Version Model Number122-10-0611
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
GS109348215042295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215042295]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-13
Device Publish Date2018-10-05

On-Brand Devices [Monoblock Tibial Trial PS Insert]

09348215042349122-10-0616
09348215042332122-10-0615
09348215042325122-10-0614
09348215042318122-10-0613
09348215042301122-10-0612
09348215042295122-10-0611
09348215042288122-10-0610
09348215042271122-10-0606
09348215042264122-10-0605
09348215042257122-10-0604
09348215042240122-10-0603
09348215042233122-10-0602
09348215042226122-10-0601
09348215042219122-10-0600
09348215042837122-10-0686
09348215042820122-10-0685
09348215042813122-10-0684
09348215042806122-10-0683
09348215042790122-10-0682
09348215042783122-10-0681
09348215042776122-10-0680
09348215042769122-10-0676
09348215042752122-10-0675
09348215042745122-10-0674
09348215042738122-10-0673
09348215042721122-10-0672
09348215042714122-10-0671
09348215042707122-10-0670
09348215042691122-10-0666
09348215042684122-10-0665
09348215042677122-10-0664
09348215042660122-10-0663
09348215042653122-10-0662
09348215042646122-10-0661
09348215042639122-10-0660
09348215042622122-10-0656
09348215042615122-10-0655
09348215042608122-10-0654
09348215042592122-10-0653
09348215042585122-10-0652
09348215042578122-10-0651
09348215042561122-10-0650
09348215042554122-10-0646
09348215042547122-10-0645
09348215042530122-10-0644
09348215042523122-10-0643
09348215042516122-10-0642
09348215042509122-10-0641
09348215042493122-10-0640
09348215042486122-10-0636

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