Trial UniPolar Head

GUDID 09348215038199

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215038199
NIH Device Record Key85a3cd97-2ba7-416c-ac8c-3e87577902db
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial UniPolar Head
Version Model Number112-33-0057
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
GS109348215038199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate
KWLProsthesis, Hip, Hemi-, Femoral, Metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215038199]

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 [Trial UniPolar Head]

09348215038229112-33-0069
09348215038212112-33-0068
09348215038205112-33-0058
09348215038199112-33-0057
09348215038182112-33-0056
09348215038175112-33-0055
09348215038168112-33-0054
09348215038151112-33-0053
09348215038144112-33-0052
09348215038137112-33-0051
09348215038120112-33-0050
09348215038113112-33-0049
09348215038106112-33-0048
09348215038090112-33-0014
09348215038083112-33-0013
09348215038076112-33-0012
09348215038069112-33-0011
09348215038052112-33-0010
09348215038045112-33-0009
09348215038038112-33-0008
09348215038021112-33-0007

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