Standard Imaging Exradin A4 Ion Chamber 92715

GUDID 00850019946239

Standard Imaging Exradin A4 is a medical device intended for absolute dose measurement for radiation (therapeutic, diagnostic, nuclear and/or environmental).

STANDARD IMAGING INC.

Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter Radiation condenser R-meter

• Primary Device ID: 00850019946239
• NIH Device Record Key: 992e27b5-d5a1-41cf-b1c2-fc0e3d0b6796
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Imaging Exradin A4 Ion Chamber
• Version Model Number: 92715
• Catalog Number: 92715
• 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	00850019946239 [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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