SB Knife™ MD-47704

GUDID 24545499064688

The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device 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.

SUMITOMO BAKELITE COMPANY LIMITED

Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 24545499064688
• NIH Device Record Key: 8b619d3a-3321-4eda-9036-3c77263e5527
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SB Knife™
• Version Model Number: Short Type
• Catalog Number: MD-47704
• Company DUNS: 690551106
• Company Name: SUMITOMO BAKELITE COMPANY LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 2.6 Millimeter
• Outer Diameter: 2.6 Millimeter
• Length: 1.8 Meter
• Outer Diameter: 2.6 Millimeter
• Length: 1.8 Meter
• Outer Diameter: 2.6 Millimeter
• Length: 1.8 Meter
• Outer Diameter: 2.6 Millimeter
• Length: 1.8 Meter
• Outer Diameter: 2.6 Millimeter
• Length: 1.8 Meter
• Outer Diameter: 2.6 Millimeter
• Length: 1.8 Meter
• Outer Diameter: 2.6 Millimeter
• Length: 1.8 Meter
• Outer Diameter: 2.6 Millimeter
• Length: 1.8 Meter
• Outer Diameter: 2.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04545499064684 [Primary]
GS1	24545499064688 [Package]; Contains: 04545499064684; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152771

FDA Product Code

• KNS: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-04
• Device Publish Date: 2016-09-12

On-Brand Devices [SB Knife™]

• 24545499064695: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704,
• 24545499064688: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704,
• 24545499064671: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704,
• 24545499064664: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704,