Catalog Number

42T9165

Brand Name

1.5T BC-10 Transmit/Receive MRI Coil

Version/Model Number

42T9165

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K031119,K031119,K031119

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Public Device Record Key

ef2a3b26-14be-4076-bf53-4a1c8dec3877

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

January 06, 2017

Package DI Number

20851607003017

Quantity per Package

1

Contains DI Package

10851607003010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper