Standard Imaging QA BeamChecker Plus 90501

GUDID 00850019946116

Standard Imaging QA BeamChecker Plus is a reliable and uncomplicated measurement instrument for daily quality assurance testing of linear accelerator, TomoTherapy Hi Art System, or other rotational delivery treatment machine output.

STANDARD IMAGING INC.

Accelerator system quality assurance device

• Primary Device ID: 00850019946116
• NIH Device Record Key: ba2b04b4-559c-4cdd-85dd-ab860a0eb9ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Imaging QA BeamChecker Plus
• Version Model Number: 90501
• Catalog Number: 90501
• Company DUNS: 788084705
• Company Name: STANDARD IMAGING 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
GS1	00850019946116 [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: 2023-06-30
• Device Publish Date: 2023-06-22

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