Visi-Pro™

Basic Information

• Brand Name: Visi-Pro™
• Primary DI: 00643169787803
• Version / Model: PXB35-07-37-135
• Company Name: Covidien LP
• Labeler DUNS: 968903703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-09
• Public Version: 4
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: a2b0a8ad-fcd6-4075-87ab-1cf58d78984d

Device Description

PXB35-07-37-135 STENT VISI PRO 035 V01

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	Stents, drains and dilators for the biliary ducts	Gastroenterology, Urology	876.5010	2
NIO	STENT, ILIAC	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, 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. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is 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
Primary	00643169787803	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P030045	002

Device Sizes

Type	Value	Unit	Text
Length	37.0	Millimeter
Outer Diameter	7.0	Millimeter
Device Size Text, specify			Max. Guidewire .89 MM
Catheter Gauge	6.0	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight