Catalog Number

103517

Brand Name

FlexStep

Version/Model Number

FlexStep V2

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PCE

Product Code Name

Permanently Mounted Wheelchair Platform Lift

Public Device Record Key

01c51a60-fe8d-4ad2-83ae-3f2400d01e4c

Public Version Date

June 11, 2021

Public Version Number

1

DI Record Publish Date

June 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-