Tracker Plus Kyphoplasty System GCD-N1300

GUDID 08809695579806

GS Medical Co., Ltd.

Balloon kyphoplasty kit
Primary Device ID08809695579806
NIH Device Record Key9f2bf6d2-51ea-4f2a-8e68-ccbee59ffcee
Commercial Distribution StatusIn Commercial Distribution
Brand NameTracker Plus Kyphoplasty System
Version Model NumberGCD-N1300
Catalog NumberGCD-N1300
Company DUNS688385418
Company NameGS Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com
Phone+82432377393
Emailudimail@gsmedi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809695579806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDNCement, Bone, Vertebroplasty

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


[08809695579806]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-01
Device Publish Date2022-10-24

On-Brand Devices [Tracker Plus Kyphoplasty System]

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

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