Fusion

Basic Information

• Brand Name: Fusion
• Primary DI: 00827002315501
• Version / Model: G31550
• Catalog Number: FS-PC-5
• Company Name: COOK IRELAND LTD
• Labeler DUNS: 988559035
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0898f0c0-9c7d-4beb-8ed6-cc11289e3146

Device Description

Fusion, Pushing Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	CATHETER, BILIARY, DIAGNOSTIC	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46689	Endoscopic stent-placement system	An assembly of sterile devices inserted through a compatible flexible endoscope to implant a stent, typically into a pancreatic or biliary duct in order to maintain patency. It typically consists of a positioning catheter onto which the stent is loaded, a guiding device (commonly known as an introducer or guidewire) that aids the initial placement of the stent, and a pusher catheter that holds the stent in place during withdrawal of the other component devices. It is commonly made of polytetrafluoroethylene (PTFE) [Teflon], or polyethylene (PE). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002315501	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry location, away from temperature extremes