Catalog Number

-

Brand Name

andorate® Single-end Bronchoscope Cleaning Brush

Version/Model Number

SDPC0199

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 20, 2020

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

da3ac197-5174-4ad1-bfe0-fa676852b812

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

August 17, 2020

Package DI Number

14897106952417

Quantity per Package

100

Contains DI Package

04897106952410

Package Discontinue Date

October 20, 2020

Package Status

Not in Commercial Distribution

Package Type

Box