Catalog Number

60-402L

Brand Name

Epi-Max™ Epistaxis Procedure Pack

Version/Model Number

60-402L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K972076,K972076

Product Code

EMX

Product Code Name

Balloon, Epistaxis

Public Device Record Key

344df339-40c5-4d68-865a-b6a9319bb46c

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

34063107101435

Quantity per Package

1

Contains DI Package

14063107101431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton