Catalog Number

NZ3223-2

Brand Name

NeoZoline

Version/Model Number

NZ3223-2

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

K061058

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

345bbc66-5ad2-4d0d-a138-93c7cfd017cb

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

February 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-