iCast Covered Stent System, 6mmX38mmX120cm 42638

GUDID 00650862426380

iCast Covered Stent System, 6mmX38mmX120cm

Atrium Medical Corporation

Peripheral artery endovascular stent-graft, non-medicated
Primary Device ID00650862426380
NIH Device Record Keye2870f2c-371f-4bfc-8b9c-b7f637674e5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameiCast Covered Stent System, 6mmX38mmX120cm
Version Model Number42638
Catalog Number42638
Company DUNS051798999
Company NameAtrium Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com
Phone888-943-8872
Emailcustomercare-US@getinge.com

Device Dimensions

Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter
Stent Diameter6 Millimeter
Stent Length38 Millimeter
Catheter Length120 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100650862426380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PRLIliac Covered Stent, Arterial

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-19
Device Publish Date2023-06-09

Devices Manufactured by Atrium Medical Corporation

00650862122916 - iCast covered stent system, 12mm x 29mm x 80cm2026-02-26 iCast covered stent system, 12mm x 29mm x 80cm
00650862122923 - iCast covered stent system, 12mm x 29mm x 120cm2026-02-26 iCast covered stent system, 12mm x 29mm x 120cm
00650862124118 - iCast covered stent system, 12mm x 41mm x 80cm2026-02-26 iCast covered stent system, 12mm x 41mm x 80cm
00650862124125 - iCast covered stent system, 12mm x 41mm x 120cm2026-02-26 iCast covered stent system, 12mm x 41mm x 120cm
00650862126112 - iCast covered stent system, 12mm x 61mm x 80cm2026-02-26 iCast covered stent system, 12mm x 61mm x 80cm
00650862126129 - iCast covered stent system, 12mm x 61mm x 120cm2026-02-26 iCast covered stent system, 12mm x 61mm x 120cm
00650862425321 - iCast covered stent system, 5mm x 32mm x 120cm2026-02-26 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

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