QUASAR Standalone ACIF System GS136-8211P

GUDID 08809885799854

Quasar Trial Without Stopper

GS Medical Co., Ltd.

Polymeric spinal interbody fusion cage

• Primary Device ID: 08809885799854
• NIH Device Record Key: 9aae4afe-ac09-4543-846e-4de91f0de4c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUASAR Standalone ACIF System
• Version Model Number: GS136-8211P
• Catalog Number: GS136-8211P
• Company DUNS: 688385418
• Company Name: GS Medical Co., Ltd.
• Device Count: 1
• DM Exempt: true
• 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
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809885799854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100516

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

[08809885799854]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-25
• Device Publish Date: 2025-03-17

On-Brand Devices [QUASAR Standalone ACIF System]

• 08809885799892: Quasar Trial Without Stopper
• 08809885799885: Quasar Trial Without Stopper
• 08809885799878: Quasar Trial Without Stopper
• 08809885799861: Quasar Trial Without Stopper
• 08809885799854: Quasar Trial Without Stopper
• 08809885799847: Quasar Trial Without Stopper
• 08809885799830: Quasar Trial Without Stopper
• 08809885799823: Quasar Trial Without Stopper
• 08809885799809: Angled Drill Tip with Sleeve
• 08809974816127: Quick Lock
• 08809974799840: SA ACIF Cage Caddy
• 08809974799833: SA ACIF Cage Caddy