Catalog Number

-

Brand Name

Na-140-Flex Coil

Version/Model Number

01790

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 15, 2020

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

K163661

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Public Device Record Key

af3b85d2-38df-42af-9436-b563a606300c

Public Version Date

December 16, 2020

Public Version Number

3

DI Record Publish Date

August 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-