Femoral Trial

GUDID 09348215040970

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215040970
NIH Device Record Key698bec86-1b5e-4f86-94d9-a7d5b23e7440
Commercial Distribution StatusIn Commercial Distribution
Brand NameFemoral Trial
Version Model Number122-10-0325
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
GS109348215040970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215040970]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-18
Device Publish Date2018-10-02

On-Brand Devices [Femoral Trial]

09348215041014122-10-0329
09348215041007122-10-0328
09348215040994122-10-0327
09348215040987122-10-0326
09348215040970122-10-0325
09348215040963122-10-0324
09348215040956122-10-0323

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