Sun Nuclear Mammo 156D Stereo Phantom

GUDID B136156D0

GAMMEX, INC.

Mammographic x-ray phantom, test object Mammographic x-ray phantom, test object Mammographic x-ray phantom, test object Mammographic x-ray phantom, test object Mammographic x-ray phantom, test object Mammographic x-ray phantom, test object Mammographic x-ray phantom, test object Mammographic x-ray phantom, test object Mammographic x-ray phantom, test object

• Primary Device ID: B136156D0
• NIH Device Record Key: 04ed8dd2-2e8d-452c-b479-776a7a681d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sun Nuclear Mammo 156D Stereo Phantom
• Version Model Number: 156D
• 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	B136156D0 [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: 2021-09-03
• Device Publish Date: 2021-08-26

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• B13614720 - Sun Nuclear Multi-Energy CT Phantom: 2021-09-06
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