Catalog Number

U1R200

Brand Name

Ultrabrush

Version/Model Number

U1R200

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

KXR

Product Code Name

APPLICATOR, RESIN

Public Device Record Key

f9404ed3-0148-4a99-938f-65ef98bbc263

Public Version Date

October 05, 2022

Public Version Number

6

DI Record Publish Date

December 08, 2020

Package DI Number

10789594000838

Quantity per Package

200

Contains DI Package

00789594000831

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tray