Patella Trial

GUDID 09348215041816

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215041816
NIH Device Record Key62fe6be6-462d-4e2d-a6d2-9ce9e275d2a5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatella Trial
Version Model Number122-10-0248
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
GS109348215041816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215041816]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-13
Device Publish Date2018-09-24

On-Brand Devices [Patella Trial]

09348215041823122-10-0249
09348215041816122-10-0248
09348215041809122-10-0247
09348215041793122-10-0246
09348215064044122-18-0017
09348215064037122-18-0016
09348215064020122-18-0015
09348215064013122-18-0014
09348215064006122-18-0013
09348215063993122-18-0012
09348215063986122-18-0011

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