Catalog Number

-

Brand Name

/

Version/Model Number

WL-500

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

OUG

Product Code Name

Medical Device Data System

Public Device Record Key

9f67ad59-49b2-482a-aab5-e77060ec7910

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Package DI Number

16948538362911

Quantity per Package

10

Contains DI Package

06948538362914

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-