MEDRAD® Disposable Prostate Coil BPX 30

GUDID 10616258009251

" MRInnervu Prostate Endorectal Coil, Compatible with 3.0 Tesla for GE, Siemens, and Marconi. (COIL,DISPOSABLE ENDORECTAL 3.0T,MC) (60727498)"

BAYER MEDICAL CARE INC.

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

• Primary Device ID: 10616258009251
• NIH Device Record Key: 1a30ec74-d0cb-434e-917e-c88d13bd3ca8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Disposable Prostate Coil
• Version Model Number: BPX 30
• Catalog Number: BPX 30
• 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	00616258009254 [Primary]
GS1	10616258009251 [Package]; Contains: 00616258009254; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051349

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® 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