Catalog Number

9430502

Brand Name

Darby Dental Supply, LLC

Version/Model Number

CaviWipes

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

-

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

LRJ

Product Code Name

Disinfectant, medical devices

Public Device Record Key

e291de55-fe69-49dc-a965-f76754c096ec

Public Version Date

May 23, 2019

Public Version Number

3

DI Record Publish Date

April 28, 2017

Package DI Number

10889813003838

Quantity per Package

12

Contains DI Package

00889813003831

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-