iCast Covered Stent System, 8mmX59mmX80cm 48859

GUDID 00650862488593

iCast Covered Stent System, 8mmX59mmX80cm

Atrium Medical Corporation

Peripheral artery endovascular stent-graft, non-medicated

• Primary Device ID: 00650862488593
• NIH Device Record Key: 3491cb75-dca2-4930-aaad-020491b027ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCast Covered Stent System, 8mmX59mmX80cm
• Version Model Number: 48859
• Catalog Number: 48859
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter
• Stent Diameter: 8 Millimeter
• Stent Length: 59 Millimeter
• Catheter Length: 80 Centimeter

Operating and Storage Conditions

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650862488593 [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: 2023-06-19
• Device Publish Date: 2023-06-09

Devices Manufactured by Atrium Medical Corporation

• 00650862420388 - iCast Covered Stent System, 10mmX38mmX120cm: 2023-06-19 iCast Covered Stent System, 10mmX38mmX120cm
• 00650862425161 - iCast Covered Stent System, 5mmX16mmX120cm: 2023-06-19 iCast Covered Stent System, 5mmX16mmX120cm
• 00650862425222 - iCast Covered Stent System, 5mmX22mmX120cm: 2023-06-19 iCast Covered Stent System, 5mmX22mmX120cm
• 00650862425383 - iCast Covered Stent System, 5mmX38mmX120cm: 2023-06-19 iCast Covered Stent System, 5mmX38mmX120cm
• 00650862425598 - iCast Covered Stent System, 5mmX59mmX120cm: 2023-06-19 iCast Covered Stent System, 5mmX59mmX120cm
• 00650862426168 - iCast Covered Stent System, 6mmX16mmX120cm: 2023-06-19 iCast Covered Stent System, 6mmX16mmX120cm
• 00650862426229 - iCast Covered Stent System, 6mmX22mmX120cm: 2023-06-19 iCast Covered Stent System, 6mmX22mmX120cm
• 00650862426380 - iCast Covered Stent System, 6mmX38mmX120cm: 2023-06-19 iCast Covered Stent System, 6mmX38mmX120cm