Sun Nuclear CB2 + 30% CaCO3 TMM

GUDID B1364840

GAMMEX, INC.

Multi-modality therapeutic radiation phantom, test object

• Primary Device ID: B1364840
• NIH Device Record Key: a2aa5831-4447-4cf9-bb84-4a2ed0ae55b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sun Nuclear CB2 + 30% CaCO3 TMM
• Version Model Number: 484
• Company DUNS: 157308230
• Company Name: GAMMEX, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
HIBCC	B1364840 [Primary]

FDA Product Code

• LHO: Instrument, Quality-Assurance, Radiologic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-06
• Device Publish Date: 2021-08-27

Devices Manufactured by GAMMEX, INC.

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• B1361150 - Sun Nuclear 115A Half Value Layer Attenuator Set: 2021-09-06
• B136115H0 - Sun Nuclear 115H Half Value Layer Attenuator Set: 2021-09-06
• B13614640 - Sun Nuclear Advanced iqModule: 2021-09-06
• B13614670 - Sun Nuclear Advanced Electron Density Phantom: 2021-09-06
• B13614720 - Sun Nuclear Multi-Energy CT Phantom: 2021-09-06
• B136159ABR0 - Sun Nuclear Phototimer Consistency Tools: 2021-09-06
• B1362000 - Sun Nuclear Low Contrast Test Tool: 2021-09-06