Bar Phantom 243-816

GUDID 00718175008164

Bar Phantom, GE

BIODEX MEDICAL SYSTEMS, INC.

Nuclear medicine phantom, test object

• Primary Device ID: 00718175008164
• NIH Device Record Key: 26dd3570-fb04-4421-bd55-7ba5d6d01932
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bar Phantom
• Version Model Number: 243-816
• Catalog Number: 243-816
• Company DUNS: 043833813
• Company Name: BIODEX MEDICAL SYSTEMS, 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: false
• Manufacturing Date: true
• 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
GS1	00718175008164 [Primary]

FDA Product Code

• JAR: Phantom, Test-Pattern, Radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-15

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• 00718175003800: Bar Phantom, Standard, High Resolution