Tibial Trial PS Insert

GUDID 09348215041953

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215041953
NIH Device Record Key1552b027-c4c0-4b45-a01e-da4ea769c716
Commercial Distribution StatusIn Commercial Distribution
Brand NameTibial Trial PS Insert
Version Model Number122-10-0438
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
GS109348215041953 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215041953]

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 PS Insert]

09348215042011122-10-0557
09348215042004122-10-0443
09348215041991122-10-0442
09348215041984122-10-0441
09348215041977122-10-0440
09348215041960122-10-0439
09348215041953122-10-0438
09348215041946122-10-0437

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.