Double-End Cleaning Brush with Port Brush - GA Health Company Limited

Duns Number:686908512

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More Product Details

Catalog Number

-

Brand Name

Double-End Cleaning Brush with Port Brush

Version/Model Number

SDPC0196-1

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"

-

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 Details

Product Code

MNL

Product Code Name

Accessories, Cleaning Brushes, For Endoscope

Device Record Status

Public Device Record Key

ada44e4e-5b53-4ef9-b32e-e3b74e8b4350

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 12, 2021

Additional Identifiers

Package DI Number

14897106953629

Quantity per Package

100

Contains DI Package

04897106953622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"GA HEALTH COMPANY LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 3