Catalog Number

EU061655

Brand Name

ACCLARENT AERA

Version/Model Number

EU061655

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

DEN150056,DEN150056

Product Code

PNZ

Product Code Name

Eustachian tube balloon dilation device

Public Device Record Key

ee717b15-5600-4691-a135-60b6d4af58e5

Public Version Date

January 22, 2020

Public Version Number

4

DI Record Publish Date

November 17, 2016

Package DI Number

20705031230887

Quantity per Package

5

Contains DI Package

10705031230880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX