Catalog Number

RH-4400-10

Brand Name

Epistax Balloon Catheter

Version/Model Number

RH-4400-10

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

d145f712-ca48-43f1-9d78-cf906406d9af

Public Version Date

August 23, 2021

Public Version Number

6

DI Record Publish Date

August 17, 2016

Package DI Number

10385640000359

Quantity per Package

10

Contains DI Package

00385640000352

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box