BioMimics 3D Vascular Stent System

Basic Information

• Brand Name: BioMimics 3D Vascular Stent System
• Primary DI: 05391526850404
• Version / Model: 142122-03
• Catalog Number: 142122-03
• Company Name: VERYAN MEDICAL LIMITED
• Labeler DUNS: 985084616
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-19
• Public Version: 7
• Public Version Date: 2024-03-01
• Public Version Status: Update
• Public Device Record Key: 25356ac0-1ceb-4c9c-9acc-0b37bddd9107

Device Description

BioMimics 3D Vascular Stent System 7.0 x 60 mm

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, 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	05391526850404	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P180003	000
P180003	001
P180003	002
P180003	003
P180003	004
P180003	005
P180003	006
P180003	007

Device Sizes

Type	Value	Unit	Text
Stent Diameter	7.0	Millimeter
Stent Length	60	Millimeter
Shaft Length	113	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry