4CIS® INSTRUMENT SYSTEM 9807-0001

GUDID 08800033343660

PEEK PLIF Cage Holder

SOLCO BIOMEDICAL CO.,LTD.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 08800033343660
• NIH Device Record Key: dc3eda36-9f0e-4d00-b7ef-c8170793a5dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS® INSTRUMENT SYSTEM
• Version Model Number: 9807-0001
• Catalog Number: 9807-0001
• Company DUNS: 687844241
• Company Name: SOLCO BIOMEDICAL CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800033343660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190563

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

[08800033343660]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-11
• Device Publish Date: 2019-12-25

On-Brand Devices [4CIS® INSTRUMENT SYSTEM]

• 08806373590139: 4CIS® Chiron-XT Compressor
• 08806373590122: 4CIS® Chiron-XT Persuader
• 08806373590115: 4CIS® Chiron-XT Rigid Rod Inserter
• 08806373590108: 4CIS® Chiron-XT Poly Axial Screw Driver
• 08806373590092: 4CIS® Chiron Tap 7.5 mm(Cannulated)
• 08806373590085: 4CIS® Chiron Tap 6.5 mm(Cannulated)
• 08806373590078: 4CIS® Chiron Tap 5.5 mm(Cannulated)
• 08806373590061: 4CIS® Chiron Tap 4.5 mm(Cannulated)
• 08806373590054: 4CIS® Chiron T-Handle Tap Ø8.5
• 08806373589935: 4CIS® Chiron Rod Rocker 6.0 type
• 08806373589898: 4CIS® In-situ Rod Bender, Left
• 08806373589881: 4CIS® In-situ Rod Bender, Right
• 08806373510564: Pedicle Probe for 6.5mm Screw
• 08800033335931: 4CIS® Chiron-XT Nut Starter Square type
• 08800033335924: 4CIS® Chiron-XT Nut Screw Dinal Driver T-handle
• 08800033335917: 4CIS® Chiron XT Nut Screw Final Driver
• 08800033335900: 4CIS® Chiron-XT Nut Starter T-handle
• 08800033335894: 4CIS® Chiron XT Nut Starter
• 08800033335887: 4CIS® Torque Stabilizer
• 08800033335870: 4CIS® Closed Ring
• 08800033335863: 4CIS® Ring C type
• 08800033335856: 4CIS® Dilator 3
• 08800033335849: 4CIS® Dilator 2
• 08800033335832: 4CIS® Dilator 1
• 08800033335825: 4CIS® Guide Wire Tool
• 08800033335818: 4CIS® Inline Rasp
• 08800033335801: 4CIS® Fixing Sleeve
• 08800033335795: 4CIS® Chiron Tap Ø8.5
• 08800033347316: Guide Wire Diamond Tip Ø1.5x500mm
• 08800033347309: Guide Wire Diamond Tip Ø1.5x480mm
• 08800033347293: Guide Wire Diamond Tip Ø1.5x450mm
• 08800033347286: Guide Wire Diamond Tip Ø1.5x400mm
• 08800033347279: Guide Wire Ø1.5x500mm
• 08800033347262: Guide Wire Ø1.5x450mm
• 08800033347255: Guide Wire Ø1.5x400mm
• 08800033347248: 4CIS® Driver T20
• 08800033342038: Guide Wire Ø1.5x480mm
• 08806373512155: Durameter Retractor
• 08800033345367: 4CIS® Augusta Cage Caddy, Option
• 08800033345350: 4CIS® Augusta Cage Caddy, W40 x D28
• 08800033345343: 4CIS® Augusta Cage Caddy, W32 x D24
• 08800033350163: 4CIS® Chiron Tap Cnnulated 8.5mm
• 08800033350156: 4CIS® Chiron Tap Cnnulated 7.5mm
• 08800033350149: 4CIS® Chiron Tap Cnnulated 6.5mm
• 08800033350132: 4CIS® Chiron Tap Cnnulated 5.5mm
• 08800033350125: 4CIS® Chiron Tap Cnnulated 4.5mm
• 08800033350118: 4CIS® Chiron Tap Non-Self Tapping 8.5mm
• 08800033350101: 4CIS® Chiron Tap Non-Self Tapping 7.5mm
• 08800033350095: 4CIS® Chiron Tap Non-Self Tapping 6.5mm
• 08800033350088: 4CIS® Chiron Tap Non-Self Tapping 5.5mm