iCast Covered Stent System, 5mmX38mmX80cm

Basic Information

• Brand Name: iCast Covered Stent System, 5mmX38mmX80cm
• Primary DI: 00650862485387
• Version / Model: 48538
• Catalog Number: 48538
• Company Name: Atrium Medical Corporation
• Labeler DUNS: 051798999
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-09
• Public Version: 1
• Public Version Date: 2023-06-19
• Public Version Status: New
• Public Device Record Key: 8f87d1a7-d103-4a4c-8292-b5408ff6fbb9

Device Description

iCast Covered Stent System, 5mmX38mmX80cm

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
PRL	Iliac Covered Stent, Arterial	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
43526	Peripheral artery endovascular stent-graft, non-medicated	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes coronary and intracranial arteries) to maintain patency and improve luminal diameter, typically in patients with symptomatic peripheral vascular disease or following the recanalization of a total occlusion; it may in addition be intended for optional venous implantation. It does not include anticoagulant or antiproliferative pharmaceuticals. It is a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft) available in various sizes. It is percutaneously inserted with a disposable delivery device which may be included with the stent-graft.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00650862485387	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P120003	000

Device Sizes

Type	Value	Unit	Text
Stent Diameter	5	Millimeter
Catheter Length	80	Centimeter
Stent Length	38	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity