SB Soft Hood /Undercut type - The Product is a transparent distal attachment - SB-KAWASUMI LABORATORIES, INC.

Duns Number:690625850

Device Description: The Product is a transparent distal attachment applied to the tip of the endoscope. It is The Product is a transparent distal attachment applied to the tip of the endoscope. It is used in ESD procedures. This Product is used for maintaining visualization during the dissection phase of the procedure. This Product contains drainage side hole that allows egress of water and blood. This Product is disposable and in a variety of diameters that correspond to different endoscope sizes.

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More Product Details

Catalog Number

-

Brand Name

SB Soft Hood /Undercut type

Version/Model Number

MD-47951

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)

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

FDS

Product Code Name

Gastroscope And Accessories, Flexible/Rigid

Device Record Status

Public Device Record Key

4852f5f3-a1db-4210-81fe-3b587c28f7dd

Public Version Date

May 30, 2022

Public Version Number

3

DI Record Publish Date

September 30, 2018

Additional Identifiers

Package DI Number

24545499068877

Quantity per Package

5

Contains DI Package

04545499068873

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SB-KAWASUMI LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 211