MEDRAD® Disposable Prostate Coil BPX 10

GUDID 10616258009237

" MRInnervu Prostate Endorectal Coil, Compatible with 1.0 Tesla for GE, Siemens, and Marconi. (PROSTATE PROBE (1.0),MC) (60727463)"

BAYER MEDICAL CARE INC.

MRI system coil, radio-frequency

• Primary Device ID: 10616258009237
• NIH Device Record Key: ffd9187d-55bf-40c2-b3a8-c3644aacb3cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Disposable Prostate Coil
• Version Model Number: BPX 10
• Catalog Number: BPX 10
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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	00616258009230 [Primary]
GS1	10616258009237 [Package]; Contains: 00616258009230; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901888

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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® Disposable Prostate Coil]

• 10616258009251: " MRInnervu Prostate Endorectal Coil, Compatible with 3.0 Tesla for GE, Siemens, and Marconi. (C
• 10616258009237: " MRInnervu Prostate Endorectal Coil, Compatible with 1.0 Tesla for GE, Siemens, and Marconi. (P
• 10616258009206: " MRInnervu Prostate Endorectal Coil, Compatible with 1.5 Tesla for GE, Siemens, and Marconi. (1
• 10616258009190: " MRInnervu Prostate Endorectal Coil, Compatible with 1.5 Tesla for GE, Siemens, and Marconi. (C