Catalog Number

34-402

Brand Name

DeRoyal

Version/Model Number

34-402

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EMX

Product Code Name

BALLOON, EPISTAXIS

Public Device Record Key

f7e1ed3d-366a-46d9-ac35-ba4237f9c360

Public Version Date

July 20, 2021

Public Version Number

1

DI Record Publish Date

July 12, 2021

Package DI Number

50749756142712

Quantity per Package

10

Contains DI Package

00749756142717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case