4CIS® INSTRUMENT SYSTEM 5901-0430

GUDID 08800033343882

4CIS® Pebble Beach PLIF Cage Holder

SOLCO BIOMEDICAL CO.,LTD.

Orthopaedic inorganic implant inserter/extractor, reusable
Primary Device ID08800033343882
NIH Device Record Key6b9c062d-be49-4574-a5d4-6d80e9f74120
Commercial Distribution StatusIn Commercial Distribution
Brand Name4CIS® INSTRUMENT SYSTEM
Version Model Number5901-0430
Catalog Number5901-0430
Company DUNS687844241
Company NameSOLCO BIOMEDICAL CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS108800033343882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

[08800033343882]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-11
Device Publish Date2019-12-25

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088063735898814CIS® In-situ Rod Bender, Right
08806373510564Pedicle Probe for 6.5mm Screw
088000333359314CIS® Chiron-XT Nut Starter Square type
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088000333359174CIS® Chiron XT Nut Screw Final Driver
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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
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08800033342038Guide Wire Ø1.5x480mm
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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
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