GENERAL HANDLE

GUDID 08800037596741

Innosys Co., 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 Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting
Primary Device ID08800037596741
NIH Device Record Key56ee9a86-efa1-4cbf-ba06-cf2f4a53a4cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENERAL HANDLE
Version Model NumberGH2010
Company DUNS688811082
Company NameInnosys Co., 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 Numbertrue
Manufacturing Datetrue
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
GS108800037596741 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


[08800037596741]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-26
Device Publish Date2024-03-18

On-Brand Devices [GENERAL HANDLE]

08800037583208GH1070
08800037583192GH1060
08800037583185GH1050
08800037583178GH1040
08800037583161GH1030
08800037583154GH1020
08800037583147GH1010
08800037583642PE0910
08800037583635PE2040
08800037580887PE0914
08800037580870PE0913
08800037580863PE0912
08800037580856PE0911
08800037596741GH2010

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