Starter Kit, 1.5T Flex Coil

GUDID 00857534006783

DEERFIELD IMAGING, INC.

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• Primary Device ID: 00857534006783
• NIH Device Record Key: 31b0daa5-e520-4bae-ae14-194bd609dfa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Starter Kit, 1.5T Flex Coil
• Version Model Number: 116768-000
• Company DUNS: 079990922
• Company Name: DEERFIELD IMAGING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	00857534006783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103506

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

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: 2023-10-12
• Device Publish Date: 2023-10-04

Devices Manufactured by DEERFIELD IMAGING, INC.

• 00857534006806 - InVision™ 3T Operating Suite: 2024-04-01
• 00857534006813 - InVision™ 1.5T Operating Suite: 2024-04-01
• 00857534006820 - IMRISeye: 2024-04-01
• 00857534006769 - IMRISeye - InVision 1.5 Surgical Theatre: 2024-03-05
• 00857534006776 - InVision 1.5 Surgical Theatre: 2024-03-05
• 00857534006783 - Starter Kit, 1.5T Flex Coil: 2023-10-12
• 00857534006783 - Starter Kit, 1.5T Flex Coil: 2023-10-12
• 00857534006790 - Starter Kit, 3T Flex Coil: 2023-10-12
• 00857534006745 - IMRIS iMRI 3T V: 2021-11-05 IMRIS IMRI 3T V