iCast covered stent system, 12mm x 29mm x 80cm

Basic Information

• Brand Name: iCast covered stent system, 12mm x 29mm x 80cm
• Primary DI: 00650862122916
• Version / Model: GBX12291A
• Company Name: Atrium Medical Corporation
• Labeler DUNS: 051798999
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-18
• Public Version: 2
• Public Version Date: 2026-04-14
• Public Version Status: Update
• Public Device Record Key: 9ee88ff8-9052-4f7b-9ba4-24d4c5ae399a

Device Description

iCast covered stent system, 12mm x 29mm x 80cm

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 aorta, coronary, pulmonary, 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 be intended for implantation in an artery adjacent to the aorta (e.g., iliac, renal), however it is not a dedicated component of an aortoiliac stent-graft assembly; it may additionally be intended for venous implantation. It is a metallic mesh-like structure with a synthetic polymer tube (endovascular graft); it does not include pharmaceuticals.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00650862122916	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P120003	009

Device Sizes

Type	Value	Unit	Text
Stent Diameter	12	Millimeter
Stent Length	29	Millimeter
Catheter Length	80	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit