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The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months.
SPATZ FGIA (ISRAEL) LTD
A-SP3US-03K
In Commercial Distribution
- 00860005178803 ()
- Appetite-suppression gastric balloon
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X200
In Commercial Distribution
- 00860008946478 ()
- 6.7mm Stent Graft Proximal Diameter
- 6.7mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 200mm Covered Stent Graft Length
TSG-6.7X200
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X150
In Commercial Distribution
- 00860008946461 ()
- 6.7mm Stent Graft Proximal Diameter
- 6.7mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 150mm Covered Stent Graft Length
TSG-6.7X150
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X100
In Commercial Distribution
- 00860008946454 ()
- 6.7mm Stent Graft Proximal Diameter
- 6.7mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 100mm Covered Stent Graft Length
TSG-6.7X100
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.0X200
In Commercial Distribution
- 00860008946447 ()
- 6.0 mm Stent Graft Proximal Diameter
- 6.0 mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 6F Delivery System Outer Profile
- 200mm Covered Stent Graft Length
TSG-6.0X200
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.0X150
In Commercial Distribution
- 00860008946430 ()
- 6.0mm Stent Graft Proximal Diameter
- 6.0mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- Covered Stent Graft Length
TSG-6.0X150
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.0X100
In Commercial Distribution
- 00860008946423 ()
- 6.0 mm Stent Graft Proximal Diameter
- 6.0 mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 100 mm Covered Stent Graft Length
TSG-6.0X100
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-5.5X200
In Commercial Distribution
- 00860008946416 ()
- 5.5 mm Stent Graft Proximal Diameter
- 5.5 mm Stent Graft Distal Diameter
- 135cm Catheter Working Length
- 8F Delivery System Outer Profile
- 200 mm Covered Stent Graft Length
TSG-5.5X200
- Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature.
PQ Bypass, Inc.
ENDOCROSS
In Commercial Distribution
- 00860008946409 ()
ENDOCROSS
- Vascular guide-catheter, single-use
Belotero Balance (+) Lidocaine is a hyaluronic-acid based dermal filler approved for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is a kitted pack containing: (1) a pre-filled, sterile Belotero Balance (+) Lidocaine gel in a 1 mL syringe, (2) two sterile needles (27G x 1/2, 30G x 1/2), and (3) two patient record labels
ANTEIS SA
8710M0S
In Commercial Distribution
- 07640123791343 ()
- Total Volume: 1.0 Milliliter
- Needle Gauge: 27 Gauge
- Needle Gauge: 30 Gauge
- Dermal tissue reconstructive material, microbe-derived, anaesthetic