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 ID10616258009237
NIH Device Record Keyffd9187d-55bf-40c2-b3a8-c3644aacb3cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDRAD® Disposable Prostate Coil
Version Model NumberBPX 10
Catalog NumberBPX 10
Company DUNS058716649
Company NameBAYER MEDICAL CARE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-7231
Emailricustomercomplaints@bayer.com
Phone+1(800)633-7231
Emailricustomercomplaints@bayer.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100616258009230 [Primary]
GS110616258009237 [Package]
Contains: 00616258009230
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
Device Publish Date2016-09-24

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

Trademark Results [MEDRAD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEDRAD
MEDRAD
85869571 4509307 Live/Registered
BAYER HEALTHCARE LLC
2013-03-07
MEDRAD
MEDRAD
78006976 2604867 Live/Registered
BAYER HEALTHCARE LLC
2000-05-05
MEDRAD
MEDRAD
75523785 2285134 Live/Registered
BAYER HEALTHCARE LLC
1998-07-23
MEDRAD
MEDRAD
75409997 2282689 Live/Registered
BAYER HEALTHCARE LLC
1997-12-23
MEDRAD
MEDRAD
75409996 2375747 Dead/Cancelled
MEDRAD, INC.
1997-12-23
MEDRAD
MEDRAD
73043970 1021990 Live/Registered
MEDRAD, INC.
1975-02-11
MEDRAD
MEDRAD
73043969 1026133 Dead/Expired
MEDRAD, INC.
1975-02-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.