MEGA SPINE SYSTEM

GUDID 08809763500787

Final Wrench(5mm)

BK MEDITECH CO.,LTD.

Surgical torque wrench, reusable
Primary Device ID08809763500787
NIH Device Record Key61f39eb1-e920-43fa-a7d6-37a946d91c70
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEGA SPINE SYSTEM
Version Model Number61650-20
Company DUNS687941818
Company NameBK MEDITECH 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 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
GS108809763500787 [Primary]

FDA Product Code

HXCWrench

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


[08809763500787]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-03
Device Publish Date2023-06-23

On-Brand Devices [MEGA SPINE SYSTEM]

08809763500282Anti-Torque Driver
08809763500251T-Wrench 3.0mm
08809763500244T-Wrench 5.0mm (Short)
08809763500237T-Wrench 5.0mm (Long)
08809763500220Multi Screw Driver
08809763500213Long arm Screw Driver
08809763500206Mono Screw Driver
08809763500183Rod Introducer
08809763500114Guide Pin
08809763500107Guide Pin
08809763501890Locking Bolt Sleeve
08809763501586Torque Limiting Wrench 3.0mm
08809763501456Anti-Torque
08809763501432Reducer
08809763501388GR Reducer
08809763501357SC Reducer
08809763501319Multi-Axial Screw Driver
08809763501302Long-Arm Screw Driver
08809763501296Mono Screw Driver
08809763501050Rod Reducer
08809763501043Anti-Torque Driver
08809763501029Pick-Up Wrench
08809763501012Multi Screw Driver
08809763501005Long-Arm Screw Driver
08809763500992Mono Screw Driver
08809763500985Long-Arm Breaker
08809763500978Distractor
08809763500961Compressor
08809763500947Awl
08809763500923Long-Arm Breaker
08809763500916Derotator
08809763500909Long-Arm Reduction Introducer
08809763500787Final Wrench(5mm)
08809763500756Multi Screw Driver
08809763500749Long-Arm Screw Driver
08809763500732Mono Screw Driver
08809763500718Bent Probe
08809763500701Straight Probe
08809763500695Awl
08809763500664T-Wrench 3.0mm
08809763500657Final Wrench(5mm)
08809763500640Pick-Up Wrench
08809763500572Multi Screw Driver
08809763500565Long-Arm Screw Driver
08809763500558Mono Screw Driver
08809763500534French Rod Bender
08809763500527Rod Rocker
08809763500510Reduction Introducer
08809763500503Alignment Driver
08809763500411Rod Pusher

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