Trial Head

GUDID 09348215038342

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215038342
NIH Device Record Key65d67113-8dec-4eda-8eda-344399b101a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrial Head
Version Model Number112-182-021
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
GS109348215038342 [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

[09348215038342]

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 Head]

09348215038410112-182-046
09348215038403112-182-045
09348215038397112-182-044
09348215038380112-182-043
09348215038373112-182-024
09348215038366112-182-023
09348215038359112-182-022
09348215038342112-182-021
09348215038335112-182-020
09348215038328112-182-019
09348215038311112-182-018
09348215038304112-182-017
09348215038298112-182-042
09348215038281112-182-041
09348215038274112-182-040

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