SB Knife /Jr type - Long - The SB Knife is a single-patient use - SB-KAWASUMI LABORATORIES, INC.

Duns Number:690625850

Device Description: The SB Knife is a single-patient use EtO-sterilized hand-held device that connects to an e The SB Knife is a single-patient use EtO-sterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker’s diverticulum within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The SB Knife is designed to connect with Olympus and ERBE connectors and uses the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators.The device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1 and IEC 60601-2-2 and IEC 60601-2-18 by UL Japan.

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More Product Details

Catalog Number

-

Brand Name

SB Knife /Jr type - Long

Version/Model Number

MD-47703L

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

KNS

Product Code Name

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Device Record Status

Public Device Record Key

0e54a692-f6fb-4e2a-b9d1-509b06894c43

Public Version Date

May 30, 2022

Public Version Number

7

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

24545499064671

Quantity per Package

1

Contains DI Package

04545499064677

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