InSitu Coil 120019-000

GUDID 00857534006554

InSitu Coil, Open, 3T Large, 120019-000

DEERFIELD IMAGING, INC.

MRI system coil, radio-frequency

• Primary Device ID: 00857534006554
• NIH Device Record Key: b3ce52cd-1ebc-43e2-a181-9dd37fd62654
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSitu Coil
• Version Model Number: InSitu Coil, Open, 3T Large
• Catalog Number: 120019-000
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00857534006554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123091

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-03-29

On-Brand Devices [InSitu Coil]

• 00857534006554: InSitu Coil, Open, 3T Large, 120019-000
• 00857534006547: InSitu Coil, Open, 1.5T Large 120018-000