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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 basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000014 ()

  • 3x12x14mm
P031214

  • Metallic spinal interbody fusion cage
The Cross-Seal Device is composed of a Catheter, Suture Delivery System, and Handle. The Cross-Seal Device tracks over a standard 0.038” or 0.035” (minimum length 130 cm) guidewire. A hemostasis valve located in the middle of the CATHETER limits blood flow from the GUIDEWIRE PORT through the CATHETER with or without the guidewire in place. The SUTURE DELIVERY SYSTEM contains NEEDLES, LOCATOR WINGS, and the NEEDLE BARREL that control suture placement around the arteriotomy. The HANDLE contains the SLIDER, BLEEDING INDICATOR, PLUNGER, RESET 1 BUTTON (SLIDER RETRACTOR), and RESET 2 BUTTON (LOCATOR WINGS RETRACTOR). The SLIDER triggers a mechanism that opens the LOCATOR WINGS and creates a sandwich configuration to stabilize the delivery system within the vessel wall. The BLEEDING INDICATOR connects to a lumen that has an intraluminal port positioned at the distal end of the Suture Delivery System to allow bleeding back to ensure Suture Delivery System is positioned properly in the femoral artery. The NEEDLE BARREL keeps the Cross-Seal Device from moving deeper inside the vessel, stabilizes the device once the LOCATOR WINGS are opened and retrieves the disengaged suture-carried NEEDLES. The PLUNGER triggers the NEEDLES to deploy sutures and simultaneously close the LOCATOR WINGS. The GUIDEWIRE GUIDE is the feature at distal handle portion which allows physician to practice coaxial insertion of device along guidewire if necessary.
MEDEON BIODESIGN, INC.
002
In Commercial Distribution

  • 04719872920359 ()
  • 04719872920366 ()
  • 04719872920373 ()
002

  • Polyolefin/fluoropolymer suture, monofilament
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
MicroPort NeuroTech (Shanghai) Co., Ltd.
3D0835FNM2
In Commercial Distribution

  • 06958698025727 ()


  • Neurovascular embolization coil
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
MicroPort NeuroTech (Shanghai) Co., Ltd.
3D0826FNM2
In Commercial Distribution

  • 06958698025710 ()


  • Neurovascular embolization coil
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
MicroPort NeuroTech (Shanghai) Co., Ltd.
3D0820FNM2
In Commercial Distribution

  • 06958698025703 ()


  • Neurovascular embolization coil
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
MicroPort NeuroTech (Shanghai) Co., Ltd.
3D0815FNM2
In Commercial Distribution

  • 06958698025697 ()


  • Neurovascular embolization coil
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
MicroPort NeuroTech (Shanghai) Co., Ltd.
3D0730FNM2
In Commercial Distribution

  • 06958698025680 ()


  • Neurovascular embolization coil
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
MicroPort NeuroTech (Shanghai) Co., Ltd.
3D0724FNM2
In Commercial Distribution

  • 06958698025673 ()


  • Neurovascular embolization coil
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
MicroPort NeuroTech (Shanghai) Co., Ltd.
3D0718FNM2
In Commercial Distribution

  • 06958698025666 ()


  • Neurovascular embolization coil
The Numen Coil Embolization System is designed to be used in conjunction with the NumenFR Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen Coil Embolization System is composed of two parts as described below: *An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter. *The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
MicroPort NeuroTech (Shanghai) Co., Ltd.
3D0712FNM2
In Commercial Distribution

  • 06958698025659 ()


  • Neurovascular embolization coil
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