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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD16
In Commercial Distribution

  • 04260182521618 ()

  • Outer Diameter: 16.5 Millimeter
37ASD16

  • Cardiac defect occluder
The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD15
In Commercial Distribution

  • 04260182521601 ()

  • Outer Diameter: 15 Millimeter
37ASD15

  • Cardiac defect occluder
The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD13
In Commercial Distribution

  • 04260182521595 ()

  • Outer Diameter: 13.5 Millimeter
37ASD13

  • Cardiac defect occluder
The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD12
In Commercial Distribution

  • 04260182521588 ()

  • Outer Diameter: 12 Millimeter
37ASD12

  • Cardiac defect occluder
The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD10
In Commercial Distribution

  • 04260182521571 ()

  • Outer Diameter: 10.5 Millimeter
37ASD10

  • Cardiac defect occluder
The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD09
In Commercial Distribution

  • 04260182521564 ()

  • Outer Diameter: 9 Millimeter
37ASD09

  • Cardiac defect occluder
The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD07
In Commercial Distribution

  • 04260182521557 ()

  • Outer Diameter: 7.5 Millimeter
37ASD07

  • Cardiac defect occluder
The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Occlutech GmbH
37ASD06
In Commercial Distribution

  • 04260182521540 ()

  • Outer Diameter: 6 Millimeter
37ASD06

  • Cardiac defect occluder
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. myCordella Handheld Patient Reader is a component of the Cordella Pulmonary Artery Sensor System. The myCordella Handheld Patient Reader (Reader) is a handheld device that is provided to the patient for at-home use to measure PA pressure on demand. The Reader wirelessly transmits the raw data obtained from the Cordella Sensor to the myCordella Tablet. The raw data is converted into readable data and sent to the myCordella Patient Management Portal for the clinician to review.
Endotronix, Inc.
100102-01
In Commercial Distribution

  • 00850008997013 ()


  • Implantable pulmonary artery pressure monitoring system
Zilver PTX, Drug-Eluting Peripheral Stent
COOK IRELAND LTD
G24939
Not in Commercial Distribution

  • 10827002249391 ()
ZIV6-35-125-8-100-PTX

  • Drug-eluting peripheral artery stent, bare-metal
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