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The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
C4 IMAGING, LLC
C-01-99-0014
Not in Commercial Distribution
- 00863593000204 ()
F-01-01-0001
- Brachytherapy source spacer
MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.
MEDICAL INFORMATION TECHNOLOGY, INC.
Client Server
In Commercial Distribution
- 00863529000117 ()
- Blood bank information system application software
MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.
MEDICAL INFORMATION TECHNOLOGY, INC.
Magic
In Commercial Distribution
- 00863529000100 ()
- Blood bank information system application software
No Description
Giles Scientific, Inc.
V3
In Commercial Distribution
- 00863504000217 ()
BV3
- Antimicrobial susceptibility/resistance testing interpretive software IVD
- Colony counter IVD, automated/semi-automated
The Compact is intended for breaking apart urinary tract stones, e.g., renal calyceal, renal pelvic, and ureteral stones.
The purpose of the Shock Wave Generator is to convert the electric energy stored in a capacitor into mechanical energy. By generating high-energy sparks under water, shock waves are produced. The reflectors then focus these waves to converge at the common therapeutic focal point (F2).
DIREX SYSTEMS CORP.
COMPACT
In Commercial Distribution
- 00863499000346 ()
- Spark-gap lithotripsy system
The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
The Duet is a transportable Extracorporeal Shock Wave Lithotripsy device, which consists of Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and Computer Console. The Duet does not provide imaging or monitoring functions, but contain the necessary interfaces for fluoroscopy and ECG R Wave Synchronization. The Duet is small and Transportable and can be used in any room equipped with the proper anesthesia devices.
Special electrodes placed within two reflectors generate high-energy sparks, which can be controlled within defined limits. The shock waves generated by the sparks are focused through water and through the body to converge on the calculus. The shock waves must be generated and transmitted through liquid to assure that sufficient energy is delivered to the stone. A series of the focused shock waves is used for the stone disintegration.
DIREX SYSTEMS CORP.
COMPACT DUET
In Commercial Distribution
- 00863499000339 ()
- Spark-gap lithotripsy system
3Dscope is intended for acquisition, processing and display of fluoroscopy images.
It can be also used together with an extra-corporeal shockwave lithotripsy.
3Dscope enables:
• Visualization of various objects on fluoroscopy images (for example, kidney stones).
• Generation and storage of patient records.
• Comparing images obtained at different times.
• Generation and management of patient data files and fluoroscopy images.
The device is composed of the following units:
• Workstation Console, which contains the application software for the system indicators and image display of the following:
System status
Fluoroscopy images
• Gantry unit, which contains he HF X-Ray generator, image intensifier and digital camera. It performs the following:
Generator control
Image initial processing
Data transfer to the Workstation console.
DIREX SYSTEMS CORP.
3DSCOPE
In Commercial Distribution
- 00863499000322 ()
- Fluoroscopic x-ray system video image recording unit
INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following:
• UCON
• Integrated unit, includes the following:
Shock Wave Generator (SWAG)
Fluoroscopy device (X-Ray Module)
Patient Table
The SWAG includes a high voltage generator module, a Reflector module, and a water module, and is located under the patient table.
The Reflector is mechanically coupled to an X-Ray Tube Monoblock. The Reflector/ Monoblock assembly is attached via a U-arm to an Image Intensifier and a digital camera Module, for real time stone imaging.
The U-Arm assembly is motorized, such that all three modules (Reflector, Monoblock, and Image Intensifier) move simultaneously as one piece and can be displaced electrically in all three axes, thus enabling the stone to be lined up in the therapeutic focal point.
The patient and table do not move. The patient lies still on the table and only the
U-Arm Assembly moves until the stone is localized.
The UCON enables control over all operational aspects of the integrated unit via a software application.
The operator chooses the various parameters to control the treatment including the number of shocks, intensity, frequency, etc.
INTEGRA contains the necessary interfaces for ECG synchronization and ultrasonic imaging devices. INTEGRA can be used in any room equipped with the proper anesthesia equipment.
DIREX SYSTEMS CORP.
INTEGRA
In Commercial Distribution
- 00863499000315 ()
- Electromechanical lithotripsy system, extracorporeal
Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and the upper ureter.
The device incorporates two electromagnetic shockwaves transducers at complementary angles to the horizon. The transducers can be operated separately (Top/Bottom) or alternate.
A series of focused shockwaves produced by electromagnetic transducers are coupled to a patient flank and are made to converge on urinary stones and disintegrate them. The patient is placed on a treatment table and x-ray and/or ultrasonic imaging device to localize the stone.
The operator controls treatment parameters including shockwave intensity, pulse rate, the number of shocks and ECG Synchronization.
DIREX SYSTEMS CORP.
MAGNA
In Commercial Distribution
- 00863499000308 ()
10-MGNA-000
- Electromechanical lithotripsy system, extracorporeal
LifeSign QuikScreen 11:
Amphetamine (AMP) 1000 ng/ml
Phencyclidine (PCP) 25 ng/ml
Methamphetamine (MET) 1000 ng/ml
Opiate (OPI) 2000 ng/ml
Barbiturates (BAR) 300 ng/ml
Benzodiazepine (BZD) 300 ng/ml
Marijuana (THC) 50 ng/ml
Methadone (MAD) 300 ng/ml
Oxycodone (OXY) 100 ng/ml
Tricyclic Antidepressants (TCA) 1000 ng/ml
Cocaine (COC) 300ng/ml
Lifesign L.L.C.
60B02
Not in Commercial Distribution
- 20863480002100 ()
- 10863480002103 ()
- 00863480002106 ()
- Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
Bone Graft Delivery Device
SPINAL SURGICAL STRATEGIES
10101-S
In Commercial Distribution
- 00863462000205 ()
10101-S
- Bone grafting cannula
No Description
CHIEF POWER CHAIR, LLC
Chief 107-ZRx
In Commercial Distribution
- 00863444000308 ()
- Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible
Body composition scale.
LEXINGTON WELLNESS HOLDINGS INC.
S-5
In Commercial Distribution
- 10863398000277 ()
- 00863398000270 ()
- 20863398000274 ()
- Bioelectrical body composition analyser
Body composition scale.
LEXINGTON WELLNESS HOLDINGS INC.
S-4
In Commercial Distribution
- 10863398000260 ()
- 00863398000263 ()
- Bioelectrical body composition analyser
Body composition scale.
LEXINGTON WELLNESS HOLDINGS INC.
S-3
In Commercial Distribution
- 10863398000246 ()
- 00863398000249 ()
- Bioelectrical body composition analyser
The Defender Room Air Cleaner ("Defender") is a portable, mechanical air filtration system
designed for single use int he home environment. It is configured as a circular unit with a
protective outer housing, a pleated fiberglass filter that exceeds HEPA filters in both efficiency
and particulate size, and an oxygen activated charcoal filter (HEGA) to remove gasses and
odors. During operation, air is drawn into the lower assembly, passes through the upper
assembly providing a 360-degree flow of air. The unit is equipped with a scent generator
powered by a small heating element. Outlet filtered air passes through the scent generator
and out from the top of the unit.
The Defender is intended to filter indoor air to remove micro-particles as small as 0.1 micron in
size. Including dust, pollen, smoke, dust mites allergens, cockroach allergens, bacteria, mold
and pet allergens. The Defender is also intended to remove Tobacco smoke and other
household odors.
Health Mor At Home Cbp
D11NA
In Commercial Distribution
- 00863342000318 ()
- High-efficiency filter air cleaner, mobile
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
RADIALOGICA LLC
1.x
In Commercial Distribution
- 00863284000315 ()
- Radiation therapy software
Gonochek®-II is intended for the use in the detection of prolyliminopeptidase, gammaglutamylaminopeptidase, and beta-galactosidase from colonies grown on selective media, to aid in the presumptive identification of Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria lactamica and Moraxella (Branhamella) catarrhalis.
Gonochek®-II consists of a reagent tube which contains three chromogenic substrates for use in the detection of three preformed enzymes, prolyliminopeptidase, gamma-glutamyl-aminopeptidase, and beta-galactosidase. These three enzymes have been shown to be accurate in identifying N.gonorrhoeae, N. meningitidis and N. lactamica respectively. The red cap of the Reagent Tube contains a color developer (diazo dye).
E-Y Laboratories, Inc.
13-003-25
In Commercial Distribution
- 00863251000218 ()
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
Unisoft ONE Single Patient Use Alternating Pressure Mattress
Unisoft Medical Corporation
UO-SPUM-800
In Commercial Distribution
- 00863220000416 ()
UO-SPUM-800
- Alternating-pressure bed mattress
Unisoft ONE Single Patient Use Therapeutic Support System
Unisoft Medical Corporation
UO-SPUS-800
In Commercial Distribution
- 00863220000409 ()
UO-SPUS-800
- Alternating-pressure bed mattress system
FIBULINK(R) SYNDESMOSIS REPAIR KIT/TI
Synthes GmbH
FGS-1100
In Commercial Distribution
- 00863176000317 ()
FGS1100
- Tendon/ligament bone anchor, non-bioabsorbable
FIBULINK(R) SYNDESMOSIS REPAIR KIT/SS
Synthes GmbH
FGS-1000
In Commercial Distribution
- 00863176000300 ()
FGS1000
- Tendon/ligament bone anchor, non-bioabsorbable
SuRgical Planner (SRP) Clinic Viewer Desktop
SURGICAL THEATER LLC
All-in-One
In Commercial Distribution
- 00863157000350 ()
- Surgical simulation system
Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 230 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1020-230
In Commercial Distribution
- 00863152000331 ()
- Limited-view-field CT system
Cone Beam Computed Tomography diagnostic extremity imaging system. Compatible with 115 Volts power outlet. 3D field of view of 17.2 cm (height) x 16cm (diameter) accommodates imaging of hand, wrist, forearm, elbow, knee, lower leg or foot. Bore platforms are interchangeable to accommodate patient size and body part. Self-shielded to reduce scatter radiation during scan. Scan time is less than 30 seconds. Scans are output as DICOM compatible 3D reconstructions, 0.2 mm multi-planar slices. In Reach system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1020-115
In Commercial Distribution
- 00863152000324 ()
- Limited-view-field CT system
Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot and ankle. Compatible with 230 Volts power outlet. 3D field of view of 20 cm (height) x 35 cm (diameter) accommodates weight bearing, bilateral imaging of both entire feet/ankles. Built-in cushioned seat allows for non-weight bearing imaging. Handlebars assist patients with entry into and exit from device. Scan time is 48 seconds or less. Scans are output as DICOM compatible 3D reconstructions, 0.3 mm multi-planar slices. PedCAT system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1000-230
In Commercial Distribution
- 00863152000317 ()
- Limited-view-field CT system
Cone Beam Computed Tomography diagnostic imaging system dedicated to the foot and ankle. Compatible with 115 Volts power outlet. 3D field of view of 20 cm (height) x 35 cm (diameter) accommodates weight bearing, bilateral imaging of both entire feet / ankles. Built-in cushioned seat allows for non-weight bearing imaging. Handlebars assist patients with entry into and exit from device. Scan time is 48 seconds or less. Scans are output as DICOM compatible 3D reconstructions, 0.3 mm multi-planar slices. PedCAT system includes acquisition station and visualization station enabled with CubeVue visualization software.
CURVEBEAM, LLC
1000-115
In Commercial Distribution
- 00863152000300 ()
- Limited-view-field CT system
Valve and Gauge Assembly
RICO SUCTION LABS INC
2066P
In Commercial Distribution
- 00863110000441 ()
- Surgical suction system
Aspirator
RICO SUCTION LABS INC
1001D
In Commercial Distribution
- 00863110000434 ()
- Surgical suction system
Aspirator
RICO SUCTION LABS INC
1001C
In Commercial Distribution
- 00863110000427 ()
- Surgical suction system
Aspirator
RICO SUCTION LABS INC
1001B
In Commercial Distribution
- 00863110000410 ()
- Surgical suction system
Aspirator
RICO SUCTION LABS INC
1001
In Commercial Distribution
- 00863110000403 ()
- Surgical suction system
Remote Central Station - Vidco Protocol
VIDCO, INC
MDP2040-0200
In Commercial Distribution
- 00863067000334 ()
- Centralized patient monitor
Remote Viewer and Charting Station for Labor and Delivery Central Station.
VIDCO, INC
MDP2040-0600RV
In Commercial Distribution
- 00863067000327 ()
- Centralized patient monitor
Labor and Delivery Central Station
VIDCO, INC
MDP2020-0600
In Commercial Distribution
- 00863067000310 ()
- Centralized patient monitor
Remote Central Station
VIDCO, INC
MDP2040-0100
In Commercial Distribution
- 00863067000303 ()
- Centralized patient monitor
Amigo Escort 7.5
AMIGO MOBILITY INTERNATIONAL, INC.
Escort 7.5
In Commercial Distribution
- 00863048000346 ()
- Assistive scooter, electric-motor-driven
Amigo Classic FD
AMIGO MOBILITY INTERNATIONAL, INC.
Classic FD
In Commercial Distribution
- 00863048000339 ()
- Assistive scooter, electric-motor-driven
Amigo HD
AMIGO MOBILITY INTERNATIONAL, INC.
HD
In Commercial Distribution
- 00863048000322 ()
- Assistive scooter, electric-motor-driven
Amigo RT Express
AMIGO MOBILITY INTERNATIONAL, INC.
RT Express
In Commercial Distribution
- 00863048000315 ()
- Assistive scooter, electric-motor-driven