Small Wonder - The Small Wonder cleaning brush is designed to - US Endoscopy

Duns Number:627879687

Device Description: The Small Wonder cleaning brush is designed to safely remove debris from channels between The Small Wonder cleaning brush is designed to safely remove debris from channels between 1.0mm and 2.0mm, such as the working channels of flexible and rigid endoscopes and accessories or devices.

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More Product Details

Catalog Number

00913302

Brand Name

Small Wonder

Version/Model Number

00913302

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

bfa37d33-c29a-4fa0-8384-d01aeec58394

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 31, 2021

Additional Identifiers

Package DI Number

10724995185081

Quantity per Package

15

Contains DI Package

00724995185084

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