Catalog Number

RC-4200

Brand Name

Epistax Balloon Catheter

Version/Model Number

RC-4200

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 07, 2021

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

54fdc989-8a5e-46c3-96d8-fd9b474ac58f

Public Version Date

August 23, 2021

Public Version Number

6

DI Record Publish Date

August 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-