Microbrush - Microbrush Anterior Nares Mid-Turbinate Test Swabs - YOUNG MICROBRUSH, LLC

Duns Number:929236305

Device Description: Microbrush Anterior Nares Mid-Turbinate Test Swabs

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More Product Details

Catalog Number

292512

Brand Name

Microbrush

Version/Model Number

292512

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

QQX

Product Code Name

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Device Record Status

Public Device Record Key

a0a2d466-ba86-459a-b434-acd1ab9ec238

Public Version Date

October 05, 2022

Public Version Number

4

DI Record Publish Date

August 16, 2022

Additional Identifiers

Package DI Number

10789594001101

Quantity per Package

100

Contains DI Package

00789594001104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package

"YOUNG MICROBRUSH, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 43