Howard Leight - Bell Ear Plug Dispenser Refill, 33dB Noise - SPERIAN HEARING PROTECTION, LLC

Duns Number:014982953

Device Description: Bell Ear Plug Dispenser Refill, 33dB Noise Reduction Rating

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More Product Details

Catalog Number

MAX-LS4E

Brand Name

Howard Leight

Version/Model Number

Leight Source

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

EWD

Product Code Name

Protector, Hearing (Insert)

Device Record Status

Public Device Record Key

a8784407-97b4-4d84-9311-b3d567b28faa

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPERIAN HEARING PROTECTION, LLC" Characteristics
Device Class Device Class Description No of Devices
U Unclassified 38