iCast covered stent system, 5mm x 32mm x 120cm

GUDID 00650862425321

iCast covered stent system, 5mm x 32mm x 120cm

Atrium Medical Corporation

Peripheral artery endovascular stent-graft, non-medicated

• Primary Device ID: 00650862425321
• NIH Device Record Key: 993a0b8e-ec84-4d3c-b56c-c9afccadd13d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCast covered stent system, 5mm x 32mm x 120cm
• Version Model Number: 42532
• Company DUNS: 051798999
• Company Name: Atrium Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-943-8872
• Email: customercare-US@getinge.com
• Phone: 888-943-8872
• Email: customercare-US@getinge.com
• Phone: 888-943-8872
• Email: customercare-US@getinge.com
• Phone: 888-943-8872
• Email: customercare-US@getinge.com

Device Dimensions

• Stent Diameter: 5 Millimeter
• Stent Length: 32 Millimeter
• Catheter Length: 120 Centimeter
• Stent Diameter: 5 Millimeter
• Stent Length: 32 Millimeter
• Catheter Length: 120 Centimeter
• Stent Diameter: 5 Millimeter
• Stent Length: 32 Millimeter
• Catheter Length: 120 Centimeter
• Stent Diameter: 5 Millimeter
• Stent Length: 32 Millimeter
• Catheter Length: 120 Centimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650862425321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P120003

FDA Product Code

• PRL: Iliac Covered Stent, Arterial

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-26
• Device Publish Date: 2026-02-18

Devices Manufactured by Atrium Medical Corporation

• 00650862122916 - iCast covered stent system, 12mm x 29mm x 80cm: 2026-02-26 iCast covered stent system, 12mm x 29mm x 80cm
• 00650862122923 - iCast covered stent system, 12mm x 29mm x 120cm: 2026-02-26 iCast covered stent system, 12mm x 29mm x 120cm
• 00650862124118 - iCast covered stent system, 12mm x 41mm x 80cm: 2026-02-26 iCast covered stent system, 12mm x 41mm x 80cm
• 00650862124125 - iCast covered stent system, 12mm x 41mm x 120cm: 2026-02-26 iCast covered stent system, 12mm x 41mm x 120cm
• 00650862126112 - iCast covered stent system, 12mm x 61mm x 80cm: 2026-02-26 iCast covered stent system, 12mm x 61mm x 80cm
• 00650862126129 - iCast covered stent system, 12mm x 61mm x 120cm: 2026-02-26 iCast covered stent system, 12mm x 61mm x 120cm
• 00650862425321 - iCast covered stent system, 5mm x 32mm x 120cm: 2026-02-26iCast covered stent system, 5mm x 32mm x 120cm
• 00650862425321 - iCast covered stent system, 5mm x 32mm x 120cm: 2026-02-26 iCast covered stent system, 5mm x 32mm x 120cm
• 00650862426328 - iCast covered stent system, 6mm x 32mm x 120cm: 2026-02-26 iCast covered stent system, 6mm x 32mm x 120cm