Catalog Number

Q605202

Brand Name

FABCO

Version/Model Number

Q605202

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

-

Product Code

KCN

Product Code Name

Ear Wick

Public Device Record Key

d30e10cb-0baa-4041-a39b-01702a0280d6

Public Version Date

April 05, 2018

Public Version Number

1

DI Record Publish Date

March 05, 2018

Package DI Number

50634303800385

Quantity per Package

50

Contains DI Package

30634303800381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser Box