Catalog Number

-

Brand Name

andorate® Single-end Bronchoscope Cleaning Brush

Version/Model Number

SDPC0199

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

ef63b985-e3fe-4b33-a5d5-3e84fe6ba35a

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 01, 2022

Package DI Number

14897106953933

Quantity per Package

100

Contains DI Package

04897106953936

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box