VISIUSeye 120028-000

GUDID 00857534006578

VISIUSeye iMRI 1.5T A and 3TS, 120028-000

DEERFIELD IMAGING, INC.

Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable Freestanding headrest, reusable

• Primary Device ID: 00857534006578
• NIH Device Record Key: ebdc973b-66c1-4e13-ad5c-1a4838a7e274
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIUSeye
• Version Model Number: VISIUSeye iMRI 1.5T A and 3TS
• Catalog Number: 120028-000
• Company DUNS: 079990922
• Company Name: DEERFIELD IMAGING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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	00857534006578 [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: 2020-09-21
• Device Publish Date: 2020-09-11

On-Brand Devices [VISIUSeye ]

• 00857534006288: VISIUSeye iMRI 1.5T A and 3TS, 117534-000
• 00857534006578: VISIUSeye iMRI 1.5T A and 3TS, 120028-000