NA - The Channel Cleaning Brush is a nylon Flexi Brush - US Endoscopy

Duns Number:627879687

Device Description: The Channel Cleaning Brush is a nylon Flexi Brush attached to a flexible plastic sheath de The Channel Cleaning Brush is a nylon Flexi Brush attached to a flexible plastic sheath designed to safely remove debris from flexible endoscopes.

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More Product Details

Catalog Number

00711601

Brand Name

NA

Version/Model Number

00711601

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MNL

Product Code Name

ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Device Record Status

Public Device Record Key

8db96ce6-49d0-4187-bd18-d5e3405199b2

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 31, 2021

Additional Identifiers

Package DI Number

10724995184930

Quantity per Package

50

Contains DI Package

00724995184933

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"US ENDOSCOPY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 51
2 A medical device with a moderate to high risk that requires special controls. 902