Catalog Number

-

Brand Name

Head/Neck Coil Set

Version/Model Number

11407660

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

K210611

Product Code

MOS

Product Code Name

Coil, magnetic resonance, specialty

Public Device Record Key

6bdb333c-9f73-4c64-9236-8f9a1b6e7e76

Public Version Date

November 17, 2021

Public Version Number

2

DI Record Publish Date

August 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-