GammaTile Radiation Shielding Tray

GUDID 00860000064514

GT MEDICAL TECHNOLOGIES, INC.

Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer Radiation shielding container, transport/transfer

• Primary Device ID: 00860000064514
• NIH Device Record Key: ba46b35d-266e-472c-87bf-4c0e59a3aede
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GammaTile Radiation Shielding Tray
• Version Model Number: GT-002
• Company DUNS: 081299204
• Company Name: GT MEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000064514 [Primary]

FDA Product Code

• KPY: Shield, Protective, Personnel

Sterilization

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

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

[00860000064514]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-21
• Device Publish Date: 2022-09-13

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