GammaTile™

GUDID 60860000064509

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: 60860000064509
• NIH Device Record Key: 81dc6a43-b90f-4e91-af15-d412c3d00ba1
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000064507 [Primary]
GS1	10860000064504 [Package]; Contains: 00860000064507; Package: outer pouch [1 Units]; In Commercial Distribution
GS1	20860000064501 [Package]; Contains: 00860000064507; Package: outer pouch [2 Units]; In Commercial Distribution
GS1	30860000064508 [Package]; Contains: 00860000064507; Package: Outer Pouch [3 Units]; In Commercial Distribution
GS1	40860000064505 [Package]; Contains: 00860000064507; Package: outer pouch [4 Units]; In Commercial Distribution
GS1	50860000064502 [Package]; Contains: 00860000064507; Package: outer pouch [5 Units]; In Commercial Distribution
GS1	60860000064509 [Package]; Contains: 00860000064507; Package: Outer Pouch [6 Units]; In Commercial Distribution

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-09-01

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
• 00860000064590 - PL-5: 2024-05-07
• 00860011485407 - PL-2: 2024-05-07
• 00860011485414 - PL-3: 2024-05-07
• 00860011485421 - PL-4: 2024-05-07