Catalog Number

-

Brand Name

NA

Version/Model Number

VT-1201-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K830228,K830228,K830228

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

0697a053-b724-4c20-80c0-01b18a2c40bc

Public Version Date

August 23, 2021

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

10385640001967

Quantity per Package

6

Contains DI Package

00385640001960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box