Tibial Trial Insert Base

GUDID 09348215041724

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215041724
NIH Device Record Keye5829836-5580-4af0-aeed-ea6bcb2ccbe0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTibial Trial Insert Base
Version Model Number122-10-0501
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
GS109348215041724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215041724]

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 [Tibial Trial Insert Base]

09348215041748122-10-0503
09348215041731122-10-0502
09348215041724122-10-0501
09348215041717122-10-0500
09348215041700122-10-0499
09348215041694122-10-0498
09348215041687122-10-0497

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