Fusion Taper Sleeve Remover Collett

GUDID 09348215080891

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID09348215080891
NIH Device Record Keyc8f945b2-81b7-4a17-a594-6fe5477ee390
Commercial Distribution StatusIn Commercial Distribution
Brand NameFusion Taper Sleeve Remover Collett
Version Model Number112-32-0236
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS109348215080891 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

Moist Heat or Steam Sterilization


[09348215080891]

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

09348215025830 - Fusion Taper Sleeve -4mm2021-05-03
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
09348215080891 - Fusion Taper Sleeve Remover Collett2021-05-03

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