Catalog Number

05-1001-653

Brand Name

Hummingbird Tympanostomy Tube System

Version/Model Number

05-1001-653

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

K142282,K200952,K142282,K200952

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

c1361dd3-3afb-433a-8d98-e1081b7c3cec

Public Version Date

April 20, 2021

Public Version Number

1

DI Record Publish Date

April 12, 2021

Package DI Number

50853386007072

Quantity per Package

10

Contains DI Package

00853386007077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Pack