TRACKER GCD2-CP1-E

GUDID 08806162110722

Cement Pusher

GS Medical Co., Ltd.

Balloon kyphoplasty kit

• Primary Device ID: 08806162110722
• NIH Device Record Key: 881a1868-a37a-4df8-869a-2070824ce03f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRACKER
• Version Model Number: GCD2-CP1-E
• Catalog Number: GCD2-CP1-E
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806162110722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192335

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

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

[08806162110722]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-07
• Device Publish Date: 2019-12-30

On-Brand Devices [TRACKER]

• 08806395400980: Tracker®GCD-1.5KIT Cement Dispenser Kit
• 08806162111392: Wire pin
• 08806162111316: Ballon Catheter normal, 20mm
• 08806162111309: Ballon Catheter normal, 15mm
• 08806162111293: Ballon Catheter normal, 10mm
• 08806162111217: Bone Expander Syringe
• 08806162111033: Spacer
• 08806162111019: Needle Pipe
• 08806162110999: Needle Pin
• 08806162110944: Expander
• 08806162110920: Cannular
• 08806162110722: Cement Pusher
• 08806162110708: Cement Filler