CS-1

GUDID 00860000064569

GT MEDICAL TECHNOLOGIES, INC.

Manual brachytherapy source, permanent implant

• Primary Device ID: 00860000064569
• NIH Device Record Key: 905c8f6c-abd1-46d4-995c-1bd95f3019f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS-1
• Version Model Number: CS-1
• 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	00860000064569 [Primary]
HIBCC	M748CS10 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030162

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-07
• Device Publish Date: 2024-04-29

On-Brand Devices [CS-1]

• 00860000064576: CS-1NS
• 00860000064569: CS-1