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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
The intended use for the ML6710i laser is photoactivation of VISUDYNE® (verteporfin for injection), which is a light-activated drug used in photodynamic therapy (PDT) for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.
Please consult the VISUDYNE® (Bausch & Lomb Incorporated) prescribing information for additional information on intended use, recommended drug and light dose, administration instructions, contraindications, warnings and precautions, and side effects of VISUDYNE® treatment.
Modulight Oyj
ML6710i
In Commercial Distribution
- 06429810677020 ()
- Ophthalmic diode laser system
Indications for FH:
The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.
Indications for FSGS:
The Apheresis Machine KANEKA MA-03 is components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KANEKA MA-03
In Commercial Distribution
- 04987671040374 ()
- Apheresis system
The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results.
The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.
Otsuka America Pharmaceutical Inc
01
In Commercial Distribution
- 00857335005008 ()
- 10857335005029 ()
- Helicobacter pylori urease IVD, kit, chromogenic
The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by the heath care professional, as ordered by a licensed health care practitioner.
MERIDIAN BIOSCIENCE, INC.
01
In Commercial Distribution
- 00840733101434 ()
- 00840733101441 ()
8209
- Helicobacter pylori urease IVD, kit, chromogenic
Soft tissue bulking agent indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency.
Uroplasty, Inc.
MPQ-2.5
In Commercial Distribution
- 08717591240266 ()
MPQ-2.5
- Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
Vesta Charger System (For OPTIMIZER Lite) consists of:
(1) Vesta Charger
(1) Battery Charger
(1) EU Plug Adapter
(1) US Plug Adapter
(1) Manual insert
Impulse Dynamics (usa) Inc.
Vesta Charger System (For OPTIMIZER Lite)
In Commercial Distribution
- 00810003380135 ()
10-F302-3-XX
- Implant battery charger
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7311
In Commercial Distribution
- 40301939736502 ()
- 00301937311505 ()
- 10301937311502 ()
- 40301937311503 ()
- 0193-7311-50 ()
- 00301937311017 ()
- 40301935540042 ()
83624710
- Glucose monitoring system IVD, home-use
SW APP A90300 RECHAGER APPLICATION
MEDTRONIC, INC.
A90300
In Commercial Distribution
- 00763000275655 ()
- Multiple active implantable device programmer