Zilver Flex

Basic Information

• Brand Name: Zilver Flex
• Primary DI: 00827002182646
• Version / Model: G18264
• Catalog Number: ZFV6-35-80-10-20
• Company Name: COOK IRELAND LTD
• Labeler DUNS: 988559035
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-04
• Public Version: 1
• Public Version Date: 2025-12-12
• Public Version Status: New
• Public Device Record Key: e7d4838a-26b2-450a-98b9-14f5f250f35e

Device Description

Zilver Flex 35 Vascular Stent

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: MR Conditional
• 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
NIP	STENT, SUPERFICIAL FEMORAL ARTERY	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47932	Peripheral artery stent, bare-metal	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. It is made entirely of metal [e.g., Nitinol alloy mesh structure] and typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10827002182643	GS1	BX	1	In Commercial Distribution
Primary	00827002182646	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the device in a dry location.