Catalog Number

-

Brand Name

Epi-Stop™ Epistaxis Catheters

Version/Model Number

60-401P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

K972077,K972077

Product Code

EMX

Product Code Name

Balloon, Epistaxis

Public Device Record Key

c14dfd92-cc1f-47f6-9662-a7db53ff7a75

Public Version Date

August 30, 2022

Public Version Number

6

DI Record Publish Date

March 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-