Catalog Number

-

Brand Name

NA

Version/Model Number

13-31-40

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

-

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

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

f7a5d453-ae25-4015-a5bc-ff04b1531860

Public Version Date

January 11, 2022

Public Version Number

4

DI Record Publish Date

October 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-