Catalog Number

M7001NM

Brand Name

RFT

Version/Model Number

10-F23936

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K160935,K160935

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Public Device Record Key

7eba7c31-7134-42ab-a825-66319d700e2e

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

August 03, 2016

Package DI Number

16938146600024

Quantity per Package

1

Contains DI Package

06938146600027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton