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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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Kit for single use during a Neuro V2 treatment guided under 3T MRI guidance. Kit content: Part Description ASM000355 PATIENT MEMBRANE PACKING ASSY SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET SET400189-AA NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
SET000960-BB Neuro V2 Kit 3T for USA
In Commercial Distribution

  • 07290015461511 ()
SET000960-BB

  • Therapeutic oncological/gynaecological ultrasound system
IPG, 16 CH, Rechargeable
ST. JUDE MEDICAL, INC.
3772
In Commercial Distribution

  • 05415067017093 ()
3772

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
IPG
ST. JUDE MEDICAL, INC.
3799
In Commercial Distribution

  • 05414734405485 ()
3799

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
8mm Tip Thermistor Ablation Catheter
IRVINE BIOMEDICAL, INC.
IBI-83445
In Commercial Distribution

  • 05414734307598 ()

  • Catheter Gauge: 7 French
IBI-83445

  • Cardiac radio-frequency ablation system catheter
Port Plug, DRG
ST. JUDE MEDICAL, INC.
7108
In Commercial Distribution

  • 15415067026993 ()
  • 05415067026996 ()
7108

  • Implantable pulse generator port plug
Edwards Certitude Delivery System
Edwards Lifesciences LLC
9630TA23
In Commercial Distribution

  • 00690103201185 ()

  • Outer Diameter, 23 MM
9630TA23A

  • Vascular catheter introduction set, nonimplantable
  • Mitral transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
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
LimFlow Extension Stent Graft (5.5 mm x 100 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-55100-US-21
In Commercial Distribution

  • 00850041730059 ()


  • Arteriovenous endovascular stent-graft
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