Catalog Number

34-103

Brand Name

DeRoyal

Version/Model Number

34-103

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"

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

11083b03-0706-425d-9acc-9396410bc0d8

Public Version Date

July 20, 2021

Public Version Number

1

DI Record Publish Date

July 12, 2021

Package DI Number

50749756142453

Quantity per Package

10

Contains DI Package

00749756142458

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case