Fusion FS-OMNI-21-260

GUDID 00827002561038

Fusion Omni-tome Preloaded Sphincterotome

COOK INCORPORATED

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00827002561038
• NIH Device Record Key: 6ab7b815-b11c-46d7-a109-bcd236cb7bdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion
• Version Model Number: G56103
• Catalog Number: FS-OMNI-21-260
• 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
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• Phone: +1(812)330-5494
• Email: sharedservices@cookmedical.com
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002561038 [Primary]

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: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-24

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
• 10827002347110: Fusion Omni Preloaded with Acrobat Wire Guide
• 10827002346939: Fusion Omni Preloaded with Acrobat Wire Guide
• 10827002346014: Fusion Omni Preloaded with Acrobat Wire Guide