Catalog Number

-

Brand Name

Flex Large 8 Coil Set 1.5T

Version/Model Number

11293133

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K183221

Product Code

MOS

Product Code Name

Coil, magnetic resonance, specialty

Public Device Record Key

be4d2675-80d2-41ac-bf3c-ce6c641002fe

Public Version Date

November 17, 2021

Public Version Number

2

DI Record Publish Date

July 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-