Catalog Number

M1385AR

Brand Name

NA

Version/Model Number

GP FLEX COIL SIGNA EXCITE 3.0T

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K030953

Product Code

MOS

Product Code Name

Coil, magnetic resonance, specialty

Public Device Record Key

7172eafa-fb30-4afb-940d-93c9c98b1c26

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

August 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-