HC300 -3T Head Coil Lower Assy

GUDID 00857534006226

Lower Assy, 3T IOH V2, 110840-000

DEERFIELD IMAGING, INC.

MRI system coil, radio-frequency

• Primary Device ID: 00857534006226
• NIH Device Record Key: 19010b66-35f8-4201-b06a-7972463ecf25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HC300 -3T Head Coil Lower Assy
• Version Model Number: HC300 Lower Coil
• 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	00857534006226 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-09-05

On-Brand Devices [HC300 -3T Head Coil Lower Assy]

• 00857534006424: Lower Assy, 3T IOH V2, 110840-600
• 00857534006226: Lower Assy, 3T IOH V2, 110840-000