Radiochromic.com

GUDID B9875X10

Radiochromic film dosimetry and radiation therapy QA software

RADIOCHROMIC SL.

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• Primary Device ID: B9875X10
• NIH Device Record Key: 906a7dc9-c162-4ced-9c75-f2a1a26abb89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiochromic.com
• Version Model Number: 5.1
• Company DUNS: 468141103
• Company Name: RADIOCHROMIC SL.
• 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
HIBCC	B9875X10 [Primary]

FDA Product Code

• MWW: Accessory - Film Dosimetry System

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: 2024-06-18
• Device Publish Date: 2024-06-10

On-Brand Devices [Radiochromic.com]

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• B9873X40: Radiochromic film dosimetry and radiation therapy QA software
• B9874X00: Radiochromic film dosimetry and radiation therapy QA software
• B9875X00: Radiochromic film dosimetry and radiation therapy QA software
• B9875X10: Radiochromic film dosimetry and radiation therapy QA software