Catalog Number

RWHA-3545I

Brand Name

RevoWave™

Version/Model Number

RWHA-3545I

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

Yes

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

OCY

Product Code Name

Endoscopic Guidewire, Gastroenterology-Urology

Public Device Record Key

de649722-6cf2-4b59-81e9-653f3324ecfb

Public Version Date

April 01, 2019

Public Version Number

1

DI Record Publish Date

March 22, 2019

Package DI Number

14545428038288

Quantity per Package

1

Contains DI Package

04545428038281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton