Catalog Number

R-02236

Brand Name

Howard Leight by Honeywell

Version/Model Number

TRUSTFIT

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EWD

Product Code Name

Protector, Hearing (Insert)

Public Device Record Key

833cd778-0723-4e4a-bc7a-324ddf6a5e65

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-