Femoral Trial CR Insert

GUDID 09348215042967

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215042967
NIH Device Record Key7d1d9236-ee8d-4666-afdf-e96a4eb85f92
Commercial Distribution StatusIn Commercial Distribution
Brand NameFemoral Trial CR Insert
Version Model Number122-10-0494
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
GS109348215042967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215042967]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-14
Device Publish Date2018-10-05

On-Brand Devices [Femoral Trial CR Insert ]

09348215042981122-10-0496
09348215042974122-10-0495
09348215042967122-10-0494
09348215042950122-10-0493
09348215042943122-10-0492
09348215042936122-10-0491
09348215042929122-10-0490

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