4CIS® INSTRUMENT SYSTEM 4901-8023

GUDID 08800033335801

4CIS® Fixing Sleeve

SOLCO BIOMEDICAL CO.,LTD.

External spinal fixation system
Primary Device ID08800033335801
NIH Device Record Key69629c53-2118-440d-991b-96b45448b5ed
Commercial Distribution StatusIn Commercial Distribution
Brand Name4CIS® INSTRUMENT SYSTEM
Version Model Number4901-8023
Catalog Number4901-8023
Company DUNS687844241
Company NameSOLCO BIOMEDICAL 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 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
GS108800033335801 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

[08800033335801]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-06
Device Publish Date2019-11-28

On-Brand Devices [4CIS® INSTRUMENT SYSTEM]

088063735901394CIS® Chiron-XT Compressor
088063735901224CIS® Chiron-XT Persuader
088063735901154CIS® Chiron-XT Rigid Rod Inserter
088063735901084CIS® Chiron-XT Poly Axial Screw Driver
088063735900924CIS® Chiron Tap 7.5 mm(Cannulated)
088063735900854CIS® Chiron Tap 6.5 mm(Cannulated)
088063735900784CIS® Chiron Tap 5.5 mm(Cannulated)
088063735900614CIS® Chiron Tap 4.5 mm(Cannulated)
088063735900544CIS® Chiron T-Handle Tap Ø8.5
088063735899354CIS® Chiron Rod Rocker 6.0 type
088063735898984CIS® In-situ Rod Bender, Left
088063735898814CIS® In-situ Rod Bender, Right
08806373510564Pedicle Probe for 6.5mm Screw
088000333359314CIS® Chiron-XT Nut Starter Square type
088000333359244CIS® Chiron-XT Nut Screw Dinal Driver T-handle
088000333359174CIS® Chiron XT Nut Screw Final Driver
088000333359004CIS® Chiron-XT Nut Starter T-handle
088000333358944CIS® Chiron XT Nut Starter
088000333358874CIS® Torque Stabilizer
088000333358704CIS® Closed Ring
088000333358634CIS® Ring C type
088000333358564CIS® Dilator 3
088000333358494CIS® Dilator 2
088000333358324CIS® Dilator 1
088000333358254CIS® Guide Wire Tool
088000333358184CIS® Inline Rasp
088000333358014CIS® Fixing Sleeve
088000333357954CIS® Chiron Tap Ø8.5
08800033347316Guide Wire Diamond Tip Ø1.5x500mm
08800033347309Guide Wire Diamond Tip Ø1.5x480mm
08800033347293Guide Wire Diamond Tip Ø1.5x450mm
08800033347286Guide Wire Diamond Tip Ø1.5x400mm
08800033347279Guide Wire Ø1.5x500mm
08800033347262Guide Wire Ø1.5x450mm
08800033347255Guide Wire Ø1.5x400mm
088000333472484CIS® Driver T20
08800033342038Guide Wire Ø1.5x480mm
08806373512155Durameter Retractor
088000333453674CIS® Augusta Cage Caddy, Option
088000333453504CIS® Augusta Cage Caddy, W40 x D28
088000333453434CIS® Augusta Cage Caddy, W32 x D24
088000333501634CIS® Chiron Tap Cnnulated 8.5mm
088000333501564CIS® Chiron Tap Cnnulated 7.5mm
088000333501494CIS® Chiron Tap Cnnulated 6.5mm
088000333501324CIS® Chiron Tap Cnnulated 5.5mm
088000333501254CIS® Chiron Tap Cnnulated 4.5mm
088000333501184CIS® Chiron Tap Non-Self Tapping 8.5mm
088000333501014CIS® Chiron Tap Non-Self Tapping 7.5mm
088000333500954CIS® Chiron Tap Non-Self Tapping 6.5mm
088000333500884CIS® Chiron Tap Non-Self Tapping 5.5mm
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