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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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LimFlow System - 00850041730110

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 System - 00850041730097

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 System - 00850041730073

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 System - 00850041730059

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

LimFlow System - 00850041730042

LimFlow Extension Stent Graft (5.5 mm x 150 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-55150-US-21
In Commercial Distribution

  • 00850041730042 ()


  • Arteriovenous endovascular stent-graft

LimFlow System - 00850041730035

LimFlow Extension Stent Graft (5.5 mm x 200 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-55200-US-21
In Commercial Distribution

  • 00850041730035 ()


  • Arteriovenous endovascular stent-graft

Sensia™ - 00643169709065

IPG SESR01 SENSIA SR IS-1 US NS
MEDTRONIC, INC.
SESR01
Not in Commercial Distribution

  • 00643169709065 ()


  • Single-chamber implantable pacemaker, rate-responsive

Adapta™ - 00643169709041

IPG ADSR01 ADAPTA SR IS-1 US NS
MEDTRONIC, INC.
ADSR01
Not in Commercial Distribution

  • 00643169709041 ()


  • Single-chamber implantable pacemaker, rate-responsive

Sensia™ - 00643169708945

IPG SESR01 SENSIA SR IS-1 US NS
MEDTRONIC, INC.
SESR01
In Commercial Distribution

  • 00643169708945 ()


  • Single-chamber implantable pacemaker, rate-responsive

Adapta™ - 00643169708860

IPG ADSR06 ADAPTA SR 5/6MM US NS
MEDTRONIC, INC.
ADSR06
Not in Commercial Distribution

  • 00643169708860 ()


  • Single-chamber implantable pacemaker, rate-responsive
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