SB Soft Hood™ MD-47961

GUDID 24545499068891

SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is used in endoscopic submucosal dissection (hereinafter ESD)

SUMITOMO BAKELITE COMPANY LIMITED

Endoscope hood Endoscope hood Endoscope hood Endoscope hood Endoscope hood Endoscope hood Endoscope hood Endoscope hood Endoscope hood

• Primary Device ID: 24545499068891
• NIH Device Record Key: 5b1e7b3d-cdf6-4ae1-9078-69ed5b74179a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SB Soft Hood™
• Version Model Number: Undercut Type
• Catalog Number: MD-47961
• 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: 15.3 Millimeter
• Outer Diameter: 15.3 Millimeter
• Outer Diameter: 15.3 Millimeter
• Outer Diameter: 15.3 Millimeter
• Outer Diameter: 15.3 Millimeter
• Outer Diameter: 15.3 Millimeter
• Outer Diameter: 15.3 Millimeter
• Outer Diameter: 15.3 Millimeter
• Outer Diameter: 15.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04545499068897 [Primary]
GS1	24545499068891 [Package]; Contains: 04545499068897; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173004

FDA Product Code

• FDS: Gastroscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-31
• Device Publish Date: 2018-09-30

On-Brand Devices [SB Soft Hood™]

• 24545499068914: SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use
• 24545499068907: SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use
• 24545499068891: SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use
• 24545499068884: SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use
• 24545499068877: SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use
• 24545499068860: SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope. It is use