Fusion Trial Trunnion Sleeve +8mm

GUDID 09348215082246

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable
Primary Device ID09348215082246
NIH Device Record Keydbaaf74d-f44e-4a21-a1b3-55287b2f273b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFusion Trial Trunnion Sleeve +8mm
Version Model Number112-32-0249
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
GS109348215082246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

Moist Heat or Steam Sterilization


[09348215082246]

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

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

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09348215025847 - Fusion Taper Sleeve 0mm2021-05-03
09348215025854 - Fusion Taper Sleeve +4mm2021-05-03
09348215025861 - Fusion Taper Sleeve +8mm2021-05-03
09348215062149 - Fusion Taper Sleeve -2mm2021-05-03
09348215062156 - Fusion Taper Sleeve +2mm2021-05-03
09348215062163 - Fusion Taper Sleeve +6mm2021-05-03
09348215080891 - Fusion Taper Sleeve Remover Collett2021-05-03

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