Catalog Number

-

Brand Name

DxTx Medical 1.5T eCoil Imaging Device (for GE)

Version/Model Number

M64ERA8-P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K053042

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Public Device Record Key

96d8a3fc-f31a-4755-be0e-0f05638e0875

Public Version Date

April 13, 2021

Public Version Number

1

DI Record Publish Date

April 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-