CS-1

GUDID 00860000064576

GT MEDICAL TECHNOLOGIES, INC.

Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant

Primary Device ID	00860000064576
NIH Device Record Key	8ba29a38-db5e-4206-b6d6-cdd65a360746
Commercial Distribution Status	In Commercial Distribution
Brand Name	CS-1
Version Model Number	CS-1NS
Company DUNS	081299204
Company Name	GT MEDICAL TECHNOLOGIES, INC.
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	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000064576 [Primary]
HIBCC	M748CS1NS0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K030162

FDA Product Code

KXK	Source, Brachytherapy, Radionuclide