Genius Tibial Trial Monobloc PS - 11mm

GUDID 09348215072384

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215072384
NIH Device Record Key2b1451ce-c3ed-4216-8138-6db7eaa44081
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenius Tibial Trial Monobloc PS - 11mm
Version Model Number122-10-0911
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 Datetrue
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
GS109348215072384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


[09348215072384]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-28
Device Publish Date2020-08-20

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