Trial BiPolar Head

GUDID 09348215045586

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215045586
NIH Device Record Key38025fc8-92fc-4850-a123-42e2acbdfefd
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial BiPolar Head
Version Model Number112-24-0053
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
GS109348215045586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215045586]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-18
Device Publish Date2018-10-05

On-Brand Devices [Trial BiPolar Head]

09348215045494112-24-0044
09348215045487112-24-0043
09348215045470112-24-0042
09348215045654112-24-0060
09348215045647112-24-0059
09348215045630112-24-0058
09348215045623112-24-0057
09348215045616112-24-0056
09348215045609112-24-0055
09348215045593112-24-0054
09348215045586112-24-0053
09348215045579112-24-0052
09348215045562112-24-0051
09348215045555112-24-0050
09348215045548112-24-0049
09348215045531112-24-0048
09348215045524112-24-0047
09348215045517112-24-0046
09348215045500112-24-0045

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