Outrigger Pin

GUDID 09348215031718

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID09348215031718
NIH Device Record Key7a40cb78-23a2-4e58-b509-34abdc2cde8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOutrigger Pin
Version Model Number122-16-0282
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
GS109348215031718 [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

[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


[09348215031718]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-05-03
Device Publish Date2019-02-18

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

09348215110246 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110253 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110260 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110277 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110284 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110291 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110307 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20
09348215110314 - Rx Knee All Poly Tibia Augment - Full - 4mm2024-11-20

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