36mm Fusion Trial Head

GUDID 09348215082178

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable
Primary Device ID09348215082178
NIH Device Record Key0963f213-0dc5-45c2-bb41-d202d9f9f1e1
Commercial Distribution StatusIn Commercial Distribution
Brand Name36mm Fusion Trial Head
Version Model Number112-32-0241
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
GS109348215082178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


[09348215082178]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

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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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