Catalog Number

Q600320

Brand Name

FABCO

Version/Model Number

Q600320

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

4c002037-9079-47f0-9572-fa87bed7e2ae

Public Version Date

December 21, 2020

Public Version Number

3

DI Record Publish Date

March 05, 2018

Package DI Number

50634303800644

Quantity per Package

20

Contains DI Package

30634303800640

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser Box