Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

48-553

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FQH

Product Code Name

LAVAGE, JET

Public Device Record Key

9dc21d44-d5fe-4147-9491-69291a56e207

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

50749756845897

Quantity per Package

10

Contains DI Package

00749756845892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case