Flexible Overtube - Flexible Overtube provides an access for repeated - SB-KAWASUMI LABORATORIES, INC.

Duns Number:690625850

Device Description: Flexible Overtube provides an access for repeated insertion and withdrawal of an endoscope Flexible Overtube provides an access for repeated insertion and withdrawal of an endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. Flexible Overtube consists of an overtube with a coiled stainless steel skelton, a detachable seal unit for an endoscope, and a detachable mouthpiece for a patient. The steel skelton of the overtube prevents the overtube from being bent and collapsed while keeping flexibility of the overtube. The detachable seal unit named “AD rubber unit” can be attached to the proximal end of the overtube to maintain insufflation and minimize leakage of air during endoscopic treatment. The overtube can be locked with the mouthpiece to maintain the proper placement of the overtube.

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More Product Details

Catalog Number

-

Brand Name

Flexible Overtube

Version/Model Number

MD-48719

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

FED

Product Code Name

Endoscopic Access Overtube, Gastroenterology-Urology

Device Record Status

Public Device Record Key

cc9e2b9a-a53e-4d78-92a7-72be66e976f0

Public Version Date

May 30, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2019

Additional Identifiers

Package DI Number

24545499070092

Quantity per Package

1

Contains DI Package

04545499070098

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