MEDRAD® 1.5T eCoil Imaging System (for Philips) 4522-132-70661

GUDID 00616258009070

"ASSY eCOIL INTERFACE dev PHILIPS 1.5T,M (60727374)"

BAYER MEDICAL CARE INC.

MRI system coil, radio-frequency MRI system coil, radio-frequency

• Primary Device ID: 00616258009070
• NIH Device Record Key: c75d03dc-1bd8-4c97-b18e-8a51194d3fc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® 1.5T eCoil Imaging System (for Philips)
• Version Model Number: 4522-132-70661
• Catalog Number: 4522-132-70661
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE 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

Customer Support Contacts

• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258009070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063342

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: 2016-09-24

On-Brand Devices [MEDRAD® 1.5T eCoil Imaging System (for Philips)]

• 10616258009213: "PROSTATE eCOIL PHILIPS 1.5T (60727390)"
• 00616258009070: "ASSY eCOIL INTERFACE dev PHILIPS 1.5T,M (60727374)"