Fusion FS-BDC-8.5

GUDID 00827002495722

Fusion Biliary Dilation Catheter

COOK INCORPORATED

Biliary drainage catheter

• Primary Device ID: 00827002495722
• NIH Device Record Key: 5670103b-29e9-4494-a25e-aeb4f612f469
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion
• Version Model Number: G49572
• Catalog Number: FS-BDC-8.5
• Company DUNS: 079720472
• Company Name: COOK INCORPORATED
• 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: true
• 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

Customer Support Contacts

• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002495722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171548

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

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: 2018-12-27
• Device Publish Date: 2018-11-26

On-Brand Devices [Fusion]

• 00827002561038: Fusion Omni-tome Preloaded Sphincterotome
• 00827002558151: Fusion Omni-tome Preloaded Sphincterotome
• 00827002558144: Fusion Omni-tome Preloaded Sphincterotome
• 00827002509771: Fusion Looptip Wire Guide
• 00827002509764: Fusion Looptip Wire Guide
• 00827002509757: Fusion Looptip Wire Guide
• 00827002495739: Fusion Biliary Dilation Catheter
• 00827002495722: Fusion Biliary Dilation Catheter
• 00827002495715: Fusion Biliary Dilation Catheter
• 00827002490918: Fusion Cytology Brush
• 00827002486768: Fusion Preloaded Omni-tome
• 00827002486751: Fusion Omni-tome
• 00827002482784: Fusion Lithotripsy Extraction Basket
• 00827002482777: Fusion Lithotripsy Extraction Basket
• 00827002319110: Fusion Preloaded Omni-tome
• 00827002319103: Fusion Ultra Short Wire Guide
• 00827002319059: Fusion Wire Guided Extraction Basket
• 00827002319035: Fusion Omni-tome Sphincterotome
• 10827002315409: Fusion Wire Guide Locking Device
• 00827002315396: Fusion Triple Lumen Needle Knife
• 00827002315389: Fusion Extraction Balloon with Multiple Sizing
• 00827002315372: Fusion Extraction Balloon with Multiple Sizing
• 00827002315334: Fusion Triple Lumen Sphincterotome
• 00827002315327: Fusion Biliary Dilation Balloon
• 00827002315310: Fusion Biliary Dilation Balloon
• 00827002315303: Fusion Biliary Dilation Balloon
• 00827002315297: Fusion Biliary Dilation Balloon
• 00827002315259: Fusion Cytology Brush
• 10827002315225: Fusion Wire Guide Locking Device
• 00827002267268: Fusion Ultra Short Wire Guide
• 10827002573038: Fusion Omni Pre-Loaded With Acrobat 2 Wire Guide
• 10827002573014: Fusion Omni Pre-Loaded With Acrobat 2 Wire Guide