Catalog Number

Q770404

Brand Name

FABCO

Version/Model Number

Q770404

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

edcdadef-1514-4b5d-a3e2-d7cece500e75

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

March 05, 2018

Package DI Number

50634303800484

Quantity per Package

10

Contains DI Package

30634303800480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser Box