Catalog Number

WLK02-W

Brand Name

DeRoyal

Version/Model Number

WLK02-W

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ITJ

Product Code Name

WALKER, MECHANICAL

Public Device Record Key

257f8007-b418-4ad7-9ce7-5581834bcd1d

Public Version Date

August 18, 2021

Public Version Number

1

DI Record Publish Date

August 10, 2021

Package DI Number

50749756624782

Quantity per Package

2

Contains DI Package

00749756624787

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case