Femoral Trial PS Insert

GUDID 09348215042202

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215042202
NIH Device Record Keyb2fb9ead-cd13-4726-9beb-fac9c0fdeb92
Commercial Distribution StatusIn Commercial Distribution
Brand NameFemoral Trial PS Insert
Version Model Number122-10-0337
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
GS109348215042202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215042202]

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 [Femoral Trial PS Insert ]

09348215042202122-10-0337
09348215042196122-10-0336
09348215042189122-10-0335
09348215042172122-10-0334
09348215042165122-10-0333
09348215042158122-10-0332
09348215042141122-10-0331

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