VISIUSeye

GUDID 00857534006295

VISIUSeye - iMRI 3T V

DEERFIELD IMAGING, INC.

Freestanding headrest, reusable

• Primary Device ID: 00857534006295
• NIH Device Record Key: edacefe2-5379-4a15-92b5-06041618cfe6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIUSeye
• Version Model Number: 117533-000
• Company DUNS: 079990922
• Company Name: DEERFIELD IMAGING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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	00857534006295 [Primary]

FDA Product Code

• FTY: Tape, Measuring, Rulers And Calipers

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: 2024-10-14
• Device Publish Date: 2024-10-04

On-Brand Devices [VISIUSeye]

• 00857534006288: VISIUSeye iMRI 1.5T A and 3TS, 117534-000
• 00857534006578: VISIUSeye iMRI 1.5T A and 3TS, 120028-000
• 00857534006585: VISIUSeye, iMRI 3T V
• 00857534006301: VISIUSeye - iCT 64
• 00857534006295: VISIUSeye - iMRI 3T V
• 00857534006271: VISIUSeye - iMRI 1.5T E