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The Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wave (CW) mode or a pulsed wave (PW) mode at manufacture (not programmable by the user). The Reprieve by Regenesis SWD device includes a base control unit, one or two treatment applicators, and an external power supply. The base control unit and treatment applicator(s) are enclosed in an injection-molded case made of medical grade poly carbonate. The treatment applicator(s) and power supply are attached to the base control unit. When not in use, the control unit acts as its own carrying case with the treatment applicators stored a slot in the Control Unit, the power supply stored in an attached pouch behind the control unit, and the treatment applicator cables stored using an attached cable management loop. The Reprieve by Regenesis SWD device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
Regenesis Biomedical, Inc.
A
In Commercial Distribution
- 00868924000038 ()
- Short-wave diathermy treatment system, home-use
InnoVoyce VYLO Eye Safety Filter Leica
Innovoyce LLC
A
In Commercial Distribution
- 00860004755999 ()
ASY-300143
- General/multiple surgical laser system beam guide, reusable
InnoVoyce VYLO 30W 455nm Laser
Innovoyce LLC
A
In Commercial Distribution
- 00860004755982 ()
ASY-300134
- General/multiple surgical diode laser system
Modern Fertility Pregnancy Test 4ct
MODERN HEALTH
A
Not in Commercial Distribution
- 00860000599634 ()
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Modern Fertility Ovulation Test 20ct
MODERN HEALTH
A
Not in Commercial Distribution
- 00860000599627 ()
- Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Modern Fertility Pregnancy Test 2ct
MODERN HEALTH
A
Not in Commercial Distribution
- 00860000599610 ()
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.
O N DIAGNOSTICS LLC
A
In Commercial Distribution
- 00860000233118 ()
- Radiology DICOM image processing application software
VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify osteoporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation.
O N DIAGNOSTICS LLC
A
In Commercial Distribution
- 00860000233101 ()
- Radiology DICOM image processing application software
The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients.
Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination.
Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller's AT 102
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution
- 04250972300134 ()
013400562
- Diagnostic spirometer, professional
Unit;2.5m, ECG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution
- 09120073932112 ()
00021
- General-purpose multi-parameter bedside monitor