Tracker Plus Kyphoplasty System GCD-N1600

GUDID 08800104089480

GS Medical Co., Ltd.

Balloon kyphoplasty kit

• Primary Device ID: 08800104089480
• NIH Device Record Key: 94be8cd8-ae48-41bb-963d-7bb6940ed5c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tracker Plus Kyphoplasty System
• Version Model Number: GCD-N1600
• Catalog Number: GCD-N1600
• 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
• Phone: +82432377393
• Email: udimail@gsmedi.com
• Phone: +82432377393
• Email: udimail@gsmedi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800104089480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211797

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

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

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

[08800104089480]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-01
• Device Publish Date: 2022-10-24

On-Brand Devices [Tracker Plus Kyphoplasty System]

• 08809695630231: GSMD-00
• 08809695619939: GVCD-1000
• 08809695619861: GCD-FD1100
• 08809695619830: GSCK-01
• 08809695619748: GSDK-01
• 08809695579998: GSMD-11
• 08809695579806: GCD-N1300
• 08809695579790: GSB-1110
• 08809695579783: GSB-1120
• 08809695579776: GSFB-1110
• 08809695579769: GSFB-1120
• 08809695576454: GCD-FF1000
• 08809695574641: GCD-1000
• 08809695574603: GSBB-00
• 08809695574597: GSIG-00
• 08809695574573: GSFB-1115
• 08809695574566: GSB-1115
• 08809695574559: GSD-1000
• 08809695574542: GCD-N1400
• 08809695574535: GCD-FD1000
• 08809695574528: GCD-F1000
• 08809695574511: GCD-S1000
• 08809695574504: GCD-N1000
• 08800104089480: GCD-N1600
• 08800104089473: GCD-N1500