Tibial Trial CR Insert

GUDID 09348215042875

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215042875
NIH Device Record Key089d1f1c-7c21-4464-8b29-530129d2378f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTibial Trial CR Insert
Version Model Number122-10-0534
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
GS109348215042875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215042875]

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 CR Insert]

09348215042912122-10-0558
09348215042905122-10-0537
09348215042899122-10-0536
09348215042882122-10-0535
09348215042875122-10-0534
09348215042868122-10-0533
09348215042851122-10-0532
09348215042844122-10-0531

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