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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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A Kit for 10 Neuro treatment (Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA). Kit content: Part Description SET001045 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T GE (5) X 2 units
INSIGHTEC LTD
SET001102 Master Treatment Kit for 3.0T (GE) Type 1.0& 1.1 NonCE/FDA
In Commercial Distribution

  • 07290015461887 ()
SET001102

  • Therapeutic oncological/gynaecological ultrasound system
LimFlow Extension Stent Graft (5.5 mm x 200 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-55200-US-24
In Commercial Distribution

  • 00850041730219 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 150 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-55150-US-24
In Commercial Distribution

  • 00850041730202 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 100 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-55100-US-24
In Commercial Distribution

  • 00850041730196 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension Stent Graft (5.5 mm x 60 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-55060-US-24
In Commercial Distribution

  • 00850041730189 ()


  • Arteriovenous endovascular stent-graft
LimFlow Crossing Stent Graft (4.0-5.5 mm x 60 mm). The LimFlow Crossing Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-40060-US-24
In Commercial Distribution

  • 00850041730172 ()


  • Arteriovenous endovascular stent-graft
LimFlow Crossing Stent Graft (3.5-5.5 mm x 60 mm). The LimFlow Crossing Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-35060-US-24
In Commercial Distribution

  • 00850041730165 ()


  • Arteriovenous endovascular stent-graft
LimFlow Conical Stent Graft (4.0-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-40060-US-21
In Commercial Distribution

  • 00850041730110 ()


  • Arteriovenous endovascular stent-graft
LimFlow Conical Stent Graft (3.5-5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-35060-US-21
In Commercial Distribution

  • 00850041730097 ()


  • Arteriovenous endovascular stent-graft
LimFlow Extension stent graft (5.5 mm x 60 mm) with the Handle Delivery System. The LimFlow System is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
SGH-55060-US-21
In Commercial Distribution

  • 00850041730073 ()


  • Arteriovenous endovascular stent-graft
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