Zilver PTX

Basic Information

• Brand Name: Zilver PTX
• Primary DI: 00827002343146
• Version / Model: G34314
• Catalog Number: ZIV6-35-125-7-80-PTX-SET
• Company Name: COOK IRELAND LTD
• Labeler DUNS: 988559035
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 6
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: bfe37033-7168-488f-9b31-118d94210b88
• Distribution End Date: 2021-11-11

Device Description

Zilver PTX, Drug-Eluting Peripheral Stent SET

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• 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
NIU	Stent, superficial femoral artery, drug-eluting	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46919	Drug-eluting peripheral artery stent, bare-metal	A non-bioabsorbable metal tubular mesh structure with a drug coating intended to be implanted into a peripheral artery (excludes aorta, coronary, and intracranial arteries) to maintain luminal patency typically in patients with symptomatic peripheral artery disease; it is not dedicated to carotid artery implantation. The drug coating is slowly released and intended to inhibit restenosis. Disposable devices associated with implantation (e.g., delivery catheter) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002343146	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dark, dry, cool place. Avoid extended exposure to light.