MEDRAD eCoil 3.0T Endo Interface Kit 8624855

GUDID 00616258021072

ASSY,PKG,KIT,SIEMENS,TIM,3T,ECOIL,ID,MC (84624527)

BAYER MEDICAL CARE INC.

MRI system coil, radio-frequency MRI system coil, radio-frequency
Primary Device ID00616258021072
NIH Device Record Key757180df-f111-4335-a1ab-4f22d7c8f27a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDRAD eCoil 3.0T Endo Interface Kit
Version Model Number8624855
Catalog Number8624855
Company DUNS058716649
Company NameBAYER MEDICAL CARE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
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
GS100616258021072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOSCoil, Magnetic Resonance, Specialty

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 Date2017-12-18

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