Catalog Number

050-6091-U3

Brand Name

HANSATON

Version/Model Number

050-6091-U3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

KLW

Product Code Name

Masker, tinnitus

Public Device Record Key

e2bc5d00-7a9a-4c97-b816-e9c2622592a6

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

December 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-