Catalog Number

3K010330

Brand Name

Everest & Jennings

Version/Model Number

3K010330

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IOR

Product Code Name

Wheelchair, Mechanical

Public Device Record Key

ba8fda5a-c7a8-4fa7-804c-ebce6795749b

Public Version Date

June 18, 2021

Public Version Number

1

DI Record Publish Date

June 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-