Catalog Number

-

Brand Name

Andorate Cleaning Brushes

Version/Model Number

SDPC0196

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 05, 2019

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"

Yes

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

8dce3070-179f-414a-be25-e40b372e8e58

Public Version Date

October 27, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2018

Package DI Number

26970934720047

Quantity per Package

8

Contains DI Package

16970934720040

Package Discontinue Date

December 05, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton