Catalog Number

-

Brand Name

andorate® Single-End Cleaning Brush with Port Brush

Version/Model Number

SDPC0197

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

MNL

Product Code Name

Accessories, Cleaning Brushes, For Endoscope

Public Device Record Key

cfe25a73-24b4-4ae8-8286-72d9a0743749

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 17, 2020

Package DI Number

14897106950628

Quantity per Package

100

Contains DI Package

04897106950621

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box