Catalog Number

292655

Brand Name

Microbrush

Version/Model Number

292655

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

QQX

Product Code Name

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Public Device Record Key

e0c9dccb-fab8-44fc-9328-fb2b35788294

Public Version Date

October 05, 2022

Public Version Number

4

DI Record Publish Date

August 16, 2022

Package DI Number

10789594001361

Quantity per Package

100

Contains DI Package

00789594001364

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package