Catalog Number

-

Brand Name

NA

Version/Model Number

GE 8ch Foot Ankle coil

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

K122694

Product Code

MOS

Product Code Name

Coil, magnetic resonance, specialty

Public Device Record Key

a9475967-77c3-4330-9fc6-d62c3e00d7e9

Public Version Date

October 27, 2022

Public Version Number

6

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-