PL-1

GUDID 00860000064583

GT MEDICAL TECHNOLOGIES, INC.

Manual brachytherapy source, permanent implant

• Primary Device ID: 00860000064583
• NIH Device Record Key: 410db14f-1ed1-42b8-a18d-0957b9681a2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PL-1
• Version Model Number: PL-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	00860000064583 [Primary]
HIBCC	M748PL10 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062384

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

Devices Manufactured by GT MEDICAL TECHNOLOGIES, INC.

• 20860000064549 - GammaTile: 2024-05-07 Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
• 00860000064569 - CS-1: 2024-05-07
• 00860000064576 - CS-1: 2024-05-07
• 00860000064583 - PL-1: 2024-05-07
• 00860000064583 - PL-1: 2024-05-07
• 00860000064590 - PL-5: 2024-05-07
• 00860011485407 - PL-2: 2024-05-07
• 00860011485414 - PL-3: 2024-05-07
• 00860011485421 - PL-4: 2024-05-07