QUASAR Standalone ACIF System GS136-6011P

GUDID 08800322709252

TRIAL, UNIVERSAL

GS Medical Co., Ltd.

Metallic spinal interbody fusion cage

• Primary Device ID: 08800322709252
• NIH Device Record Key: 03025af8-2507-4fe6-89ce-a91c94250842
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUASAR Standalone ACIF System
• Version Model Number: GS136-6011P
• Catalog Number: GS136-6011P
• Company DUNS: 688385418
• Company Name: GS Medical 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: true
• 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

Customer Support Contacts

• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800322709252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221687

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

[08800322709252]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-28
• Device Publish Date: 2025-07-18

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• 08809885799809: Angled Drill Tip with Sleeve
• 08809974816127: Quick Lock
• 08809974799840: SA ACIF Cage Caddy
• 08809974799833: SA ACIF Cage Caddy
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• 08800322709566: TRIAL, UNIVERSAL
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• 08800322709443: TRIAL, UNIVERSAL
• 08800322709436: TRIAL, UNIVERSAL
• 08800322709429: TRIAL, UNIVERSAL
• 08800322709412: TRIAL, UNIVERSAL
• 08800322709405: TRIAL, UNIVERSAL
• 08800322709399: TRIAL, UNIVERSAL
• 08800322709382: TRIAL, UNIVERSAL
• 08800322709375: TRIAL, UNIVERSAL
• 08800322709368: TRIAL, UNIVERSAL
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• 08800322709344: TRIAL, UNIVERSAL
• 08800322709337: TRIAL, UNIVERSAL
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• 08800322709252: TRIAL, UNIVERSAL
• 08800322709245: TRIAL, UNIVERSAL
• 08800322709238: TRIAL, UNIVERSAL
• 08800322709221: TRIAL, UNIVERSAL
• 08800322709214: SA ACIF Holder