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Redondo-L 45mm x 18mm x 8mm, 8 Deg. Redondo-L is intended to promote spinal fusion by acting as a spacer and holding bone graft. The implants have teeth on the superior and inferior surfaces and a central canal for receiving bone graft. These devices are available in a variety of lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All Redondo-L implants are manufactured from PEEK OPTIMA®(polyetheretherketone, ASTM F-2026) with tantalum (ASTM F-560) radiographic wires and/or beads.
Seaspine Orthopedics Corporation
36-4516
Not in Commercial Distribution
- 10889981035044 ()
- 45mm x 18mm x 16mm, 8 degrees
36-4516
- Vertebral body prosthesis, non-sterile
The TS-310 is a space-saving automated refraction system that uses a combination of the refractor head of the RT-3100 and a control box.
• With the high precision LCD, visual acuity of 5 m as well as near visual acuity of 40 cm can be measured with the same accuracy as a standard refraction using actual distances.
• The objective data measured by a NIDEK auto refractometer and the lensometry data measured by a NIDEK lensmeter can be imported and used in this device.
NIDEK CO.,LTD.
TS-310
In Commercial Distribution
- 04987669101414 ()
- Vision testing/training chart
- Phoropter
The ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities.
The ReJoyce helps patients to retrain and condition their muscles by using their hands and arms to play interactive computer games.
The activities required by the computer games are similar to tasks used in everyday life, such as pouring a drink or opening a jar. Practicing these motions will help patients to replicate them in real life.
Rehabtronics Inc
RV10
In Commercial Distribution
- 17540176010002 ()
- Virtual-display arm rehabilitation system, non-gravity-compensating
The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), analysis of coronary blood flow and coronary flow reserve, and assessment of cardiac mechanic dyssynchrony. In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, and expert system image interpretation. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, Rubidium-82 with CT-based attenuation correction, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the .NET operating system environment which can be executed on any PC, any nuclear medicine computer system, or through a web browser. In addition, the program can be used for the decision support in interpretation and automatic structured reporting of the study. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
4.0.5121.18001
In Commercial Distribution
- B133ECTB40 ()
- Cardiovascular risk evaluation interpretive software
The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the shape of the fundus or retina. Fundus surface images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the retina (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape and structure of the fundus or retina can be observed, and diseases can be observed. This system is comprised of the main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, PC monitor, and an isolation transformer.
In addition, the image filing software NAVIS-EX (hereafter referred to as NAVIS-EX) offers the following features:
• Image analysis functions such as 3D/map color display or retinal thickness analysis
• Networking for data review or analysis on PCs in separate locations
NIDEK CO.,LTD.
RS-3000 Advance
In Commercial Distribution
- 04987669100516 ()
- Direct ophthalmoscope, line-powered
The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of
bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to
determine the minimum inhibitory concentration (MIC) in µglmL of antimicrobial agents against bacteria as tested on agar media using ovemight
incubation and manual reading procedures. The MTS™ Eravacycline at concentrations of 0.002-32 µglmL should be interpreted at 16-20 hours of
incubation.
MTS™ Eravacycline can be used to dete1mine the MIC of eravacycline against the following bacteria.
Eravacycline has been shown to be active both clinically and in vitro against these bacterial species accoring to the FDA drug approved label:
Gram-positive bacteria
Enterococcus faecalis
Enterococcus faecium
Staphylococcus aureus
Gram-negative bacteria
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below accoring to the FDA drug aprroved label:
Citrobacter koseri
Klebsiella (Enterobacter) aerogenes
LIOFILCHEM SRL
Eravacycline ERV 0.002-32 µg/mL 10 STRIP
In Commercial Distribution
- 18055182872906 ()
- 08055182872909 ()
- 08055182872886 ()
92104-10
- Eravacycline minimum inhibitory concentration (MIC) IVD
The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of
bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to
determine the minimum inhibitory concentration (MIC) in µglmL of antimicrobial agents against bacteria as tested on agar media using ovemight
incubation and manual reading procedures. The MTS™ Eravacycline at concentrations of 0.002-32 µglmL should be interpreted at 16-20 hours of
incubation.
MTS™ Eravacycline can be used to dete1mine the MIC of eravacycline against the following bacteria.
Eravacycline has been shown to be active both clinically and in vitro against these bacterial species accoring to the FDA drug approved label:
Gram-positive bacteria
Enterococcus faecalis
Enterococcus faecium
Staphylococcus aureus
Gram-negative bacteria
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below accoring to the FDA drug aprroved label:
Citrobacter koseri
Klebsiella (Enterobacter) aerogenes
LIOFILCHEM SRL
Eravacycline ERV 0.002-32 µg/mL 1 STRIP
In Commercial Distribution
- 08055182872893 ()
- 28055182872897 ()
- 18055182872890 ()
92104-1
- Eravacycline minimum inhibitory concentration (MIC) IVD
ADAPTER, QUICK DRAIN, LEVER OPERATED, URINE COLLECTION, LEG BAG, MALE URINAL, REUSABLE
Only a limited amount of finger or hand control is required to operate these valves independently. Finger loops or a crossbar may be attached to te lever for individual requirements. Fits Urocare® Reusable Latex Leg Bags and Urocare® Male Urinal Sheaths only. Made with pliable, white-rubber tubing and plastic—no metal parts to corrode. May be
used as a replacement for the Standard Bottom Drain Valve (#6004) included with all reusable latex leg bags and Male Urinal Sheaths. An effective crossbar can be made by cutting 2" (5cm) from the bottom of the drain valve tube and pushing one end through the hole in the lever until it is centered, forming a “T” shaped bar.
Features:
• Lever operated for quick, controlled drainage
• Threads are sealed to prevent urine from touching the skin while draining the bag
• All working parts are urine free
• No metal parts or sharp corners
• Tube may be cut to desired length
Includes Gasket-Ring #5999 preassembled.
UROCARE PRODUCTS, INC.
700172
In Commercial Distribution
- 00792293701725 ()
- Lumen/Inner Diameter: 6 Millimeter
- Length: 183 Centimeter
- Weight: 0.06 Pound
- Length: 72 Inch
- Lumen/Inner Diameter: 0.25 Inch
700172
- Penis/scrotum wearable urinal
- Open-ended wearable urine collection bag, non-sterile
ADAPTER, QUICK DRAIN, LEVER OPERATED, URINE COLLECTION, LEG BAG, MALE URINAL, REUSABLE
Only a limited amount of finger or hand control is required to operate these valves independently. Finger loops or a crossbar may be attached to te lever for individual requirements. Fits Urocare® Reusable Latex Leg Bags and Urocare® Male Urinal Sheaths only. Made with pliable, white-rubber tubing and plastic—no metal parts to corrode. May be
used as a replacement for the Standard Bottom Drain Valve (#6004) included with all reusable latex leg bags and Male Urinal Sheaths. An effective crossbar can be made by cutting 2" (5cm) from the bottom of the drain valve tube and pushing one end through the hole in the lever until it is centered, forming a “T” shaped bar.
Features:
• Lever operated for quick, controlled drainage
• Threads are sealed to prevent urine from touching the skin while draining the bag
• All working parts are urine free
• No metal parts or sharp corners
• Tube may be cut to desired length
Includes Gasket-Ring #5999 preassembled.
UROCARE PRODUCTS, INC.
700118
In Commercial Distribution
- 00792293701183 ()
- Lumen/Inner Diameter: 0.25 Inch
- Length: 18 Inch
- Weight: 0.06 Pound
- Length: 45 Centimeter
- Lumen/Inner Diameter: 6 Millimeter
700118
- Open-ended wearable urine collection bag, non-sterile
- Penis/scrotum wearable urinal
ADAPTER, QUICK DRAIN, LEVER OPERATED, URINE COLLECTION, LEG BAG, MALE URINAL, REUSABLE
Only a limited amount of finger or hand control is required to operate these valves independently. Finger loops or a crossbar may be attached to te lever for individual requirements. Fits Urocare® Reusable Latex Leg Bags and Urocare® Male Urinal Sheaths only. Made with pliable, white-rubber tubing and plastic—no metal parts to corrode. May be
used as a replacement for the Standard Bottom Drain Valve (#6004) included with all reusable latex leg bags and Male Urinal Sheaths. An effective crossbar can be made by cutting 2" (5cm) from the bottom of the drain valve tube and pushing one end through the hole in the lever until it is centered, forming a “T” shaped bar.
Features:
• Lever operated for quick, controlled drainage
• Threads are sealed to prevent urine from touching the skin while draining the bag
• All working parts are urine free
• No metal parts or sharp corners
• Tube may be cut to desired length
Includes Gasket-Ring #5999 preassembled.
UROCARE PRODUCTS, INC.
700110
In Commercial Distribution
- 10792293701104 ()
- 00792293701107 ()
- 20792293701101 ()
- Lumen/Inner Diameter: 6 Millimeter
- Length: 25 Centimeter
- Weight: 0.06 Pound
- Length: 10 Inch
- Lumen/Inner Diameter: 0.25 Inch
700110
- Penis/scrotum wearable urinal
- Open-ended wearable urine collection bag, non-sterile