Catalog Number

M7001KM

Brand Name

RFT

Version/Model Number

10-F21457

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

K151653,K160932,K151653,K160932

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Public Device Record Key

ed277aac-8c1e-4ed1-bfb9-3425fc1e4e44

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

March 30, 2016

Package DI Number

16938146600017

Quantity per Package

1

Contains DI Package

06938146600010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton