Sun Nuclear CT Dose Index

GUDID B136468BH0

GAMMEX, INC.

CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object CT phantom, test object

• Primary Device ID: B136468BH0
• NIH Device Record Key: 6b137a91-f74b-4fbe-87de-0c67c486b6d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sun Nuclear CT Dose Index
• Version Model Number: 468BH
• 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	B136468BH0 [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