Primary Device ID | 00650862480382 |
NIH Device Record Key | cffbf2c2-98ed-4ab9-b340-9f1ff1c93c50 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | iCast Covered Stent System, 10mmX38mmX80cm |
Version Model Number | 48038 |
Catalog Number | 48038 |
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 |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com | |
Phone | 888-943-8872 |
customercare-US@getinge.com |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
Stent Diameter | 10 Millimeter |
Stent Length | 38 Millimeter |
Catheter Length | 80 Centimeter |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00650862480382 [Primary] |
PRL | Iliac Covered Stent, Arterial |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-19 |
Device Publish Date | 2023-06-09 |
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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 |