Leader - Soft Foam Earplugs 10 Pairs - CIRRUS HEALTHCARE PRODUCTS LLC

Duns Number:809994163

Device Description: Soft Foam Earplugs 10 Pairs

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More Product Details

Catalog Number

-

Brand Name

Leader

Version/Model Number

81025

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)

Yes

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

a0256a74-fac7-4dd6-935c-ff8e5b389539

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 21, 2019

Additional Identifiers

Package DI Number

10096295133889

Quantity per Package

1

Contains DI Package

00096295133882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Unit

"CIRRUS HEALTHCARE PRODUCTS LLC" Characteristics
Device Class Device Class Description No of Devices
U Unclassified 4