Sun Nuclear BR12 Breast

GUDID B1364530

GAMMEX, INC.

Multi-modality therapeutic radiation phantom, test object Multi-modality therapeutic radiation phantom, test object Multi-modality therapeutic radiation phantom, test object Multi-modality therapeutic radiation phantom, test object Multi-modality therapeutic radiation phantom, test object Multi-modality therapeutic radiation phantom, test object Multi-modality therapeutic radiation phantom, test object Multi-modality therapeutic radiation phantom, test object Multi-modality therapeutic radiation phantom, test object Multi-modality therapeutic radiation phantom, test object

• Primary Device ID: B1364530
• NIH Device Record Key: 4204ec1b-2445-42e2-8333-0902f863ecc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sun Nuclear BR12 Breast
• Version Model Number: 453
• 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	B1364530 [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

On-Brand Devices [Sun Nuclear BR12 Breast]

• B1364540: 454
• B1364530: 453