Catalog Number

-

Brand Name

NA

Version/Model Number

OT-5200-25

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"

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

-

Product Code

KCN

Product Code Name

Ear Wick

Public Device Record Key

25ec0a25-1d4f-4b83-a1b8-6c8f1d51c9a6

Public Version Date

August 23, 2021

Public Version Number

4

DI Record Publish Date

October 11, 2016

Package DI Number

10385640023891

Quantity per Package

25

Contains DI Package

00385640023894

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box