Brisbane Trial Cage

GUDID 09348215044381

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215044381
NIH Device Record Key6f47c373-8a09-40d0-bbe3-9d08e3164e07
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrisbane Trial Cage
Version Model NumberW32-01-5123
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
GS109348215044381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215044381]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-07-02
Device Publish Date2018-10-05

On-Brand Devices [Brisbane Trial Cage]

09348215044428W32-01-5165
09348215044411W32-01-5163
09348215044404W32-01-5161
09348215044398W32-01-5125
09348215044381W32-01-5123
09348215044374W32-01-5121
09348215044367W32-01-5085
09348215044350W32-01-5083
09348215044343W32-01-5081
09348215044336W32-01-4165
09348215044329W32-01-4163
09348215044312W32-01-4161
09348215044305W32-01-4127
09348215044299W32-01-4125
09348215044282W32-01-4123
09348215044275W32-01-4121
09348215044268W32-01-4087
09348215044251W32-01-4085
09348215044244W32-01-4083
09348215044237W32-01-4081
09348215044220W32-01-3165
09348215044213W32-01-3163
09348215044206W32-01-3161
09348215044190W32-01-3125
09348215044183W32-01-3123
09348215044176W32-01-3121
09348215044152W32-01-3083
09348215044145W32-01-3081
09348215044169W32-01-3085

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