Catalog Number

-

Brand Name

Hummingbird Tympanostomy Tube System

Version/Model Number

05-1001-503

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2022

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

-

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

dee070fa-ff46-4306-b33a-5894d180d061

Public Version Date

August 16, 2022

Public Version Number

6

DI Record Publish Date

August 31, 2017

Package DI Number

00853386007046

Quantity per Package

5

Contains DI Package

00853386007039

Package Discontinue Date

August 01, 2022

Package Status

Not in Commercial Distribution

Package Type

Box