Fusion Taper Remover Screw Grip

GUDID 09348215080907

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 ID09348215080907
NIH Device Record Keybea01468-8bfb-4890-a290-b590a5390fe0
Commercial Distribution StatusIn Commercial Distribution
Brand NameFusion Taper Remover Screw Grip
Version Model Number112-32-0237
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
GS109348215080907 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

Moist Heat or Steam Sterilization


[09348215080907]

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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