Catalog Number

23-60427

Brand Name

Invotec Tympanostomy Tube

Version/Model Number

1

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

K903285,K903285

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

92cffab6-bdd2-4670-8b78-32d124f10995

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

January 03, 2017

Package DI Number

10818501020628

Quantity per Package

10

Contains DI Package

00818501020621

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box