GammaTile

GUDID 20860000064549

Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier

GT MEDICAL TECHNOLOGIES, INC.

Manual brachytherapy source, permanent implant

• Primary Device ID: 20860000064549
• NIH Device Record Key: d4fbbf49-c9eb-4f61-9cee-d7288dbf9409
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GammaTile
• Version Model Number: GT-001
• Company DUNS: 081299204
• Company Name: GT MEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00860000064545 [Primary]
GS1	10860000064542 [Package]; Contains: 00860000064545; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20860000064549 [Package]; Contains: 00860000064545; Package: Inner Pack [2 Units]; In Commercial Distribution
GS1	30860000064546 [Package]; Contains: 00860000064545; Package: Inner Pack [3 Units]; In Commercial Distribution
GS1	40860000064543 [Package]; Contains: 00860000064545; Package: Inner Pack [4 Units]; In Commercial Distribution
GS1	50860000064540 [Package]; Contains: 00860000064545; Package: Inner Pack [5 Units]; In Commercial Distribution
GS1	60860000064547 [Package]; Contains: 00860000064545; Package: Inner Pack [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221539

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