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A non-sterile substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.
AMERICAN DENTAL PRODUCTS INC
DDS
Not in Commercial Distribution
- 00865849000204 ()
- Dental coating, tooth-desensitizing
cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution
- EBCI80600 ()
- Electroencephalographic spectrum analyser
MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.
Infobionic, Inc.
01854
In Commercial Distribution
- B690MK10 ()
- Electrocardiography telemetric monitoring system transmitter
Multiple clinical chemistry analyser IVD, laboratory, semi-automated:
An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.
BIOTECNICA INSTRUMENTS SPA
Envoy 500+ S/I
In Commercial Distribution
- 08033622964551 ()
03-07051-01
- Multiple clinical chemistry analyser IVD, laboratory, semi-automated
Multiple clinical chemistry analyser IVD, laboratory, semi-automated:
An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.
BIOTECNICA INSTRUMENTS SPA
Envoy 500+
In Commercial Distribution
- 08033622964544 ()
03-07050-01
- Multiple clinical chemistry analyser IVD, laboratory, semi-automated
Multiple clinical chemistry analyser IVD, laboratory, semi-automated:
An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.
BIOTECNICA INSTRUMENTS SPA
Envoy 500
In Commercial Distribution
- 08033622963257 ()
03-04444-30
- Multiple clinical chemistry analyser IVD, laboratory, semi-automated
The Televisit software is intended for the purposes of collecting physiological data such as: Non-Invasive Blood Pressure; Pulse Oximetry, Temperature and Breath Sounds (Auscultation), Spirometer, Glucometer and E.C.G.
The intended use of the Televisit software is in hospital/clinical environments with established specialized care providing access to each patient in their home and/or local community health center. Televisit software is a non-invasive medical device, which does not flag any abnormal results from the medical device inputs. The Televisit software does not monitor, assess or diagnose a disease, a disorder, or an abnormal physical state. The intended use for the software is data acquisition and collection only, with no treatment function or danger to the end user. The data obtained from Televisit software can be used only as an aid in the diagnosis and treatment of the patient.
Primonics (2006) Inc
TVS
In Commercial Distribution
- 00628250477016 ()
- Pulse oximeter, line-powered
The Piccolo Xpress chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. This kit contains additional accessories for supporting US military requirements.
The Piccolo Xpress is a portable clinical chemistry system designed for accurate, on-site patient testing.
It allows healthcare practitioners to perform routine multi-chemistry panels using 0.1cc of whole blood, serum or plasma. The system uses patented single-use reagent discs which contain up to 14 chemistry tests.
Simply pipette the sample into the disc, insert the disc into the analyzer and results are printed or transferred to an LIS/EMR in about 12 minutes. No operator intervention is required.
The Piccolo Xpress employs on-board continuous intelligent Quality Control (iQC®) to monitor the analyzer, reagent reactions and sample to ensure the highest quality and accuracy in results.
ABAXIS, INC.
1100-1511
In Commercial Distribution
- EABA11001511 ()
- Height: 32.5 Centimeter
- Width: 14.9 Centimeter
- Depth: 21.0 Centimeter
- Weight: 5.3 Kilogram
1100-1511
- Centrifugal clinical chemistry analyser
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure.
The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm.
There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire.
Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution
- 00860005968800 ()
- Orthopaedic bone screw, non-bioabsorbable, sterile
Bony fixation of Panta nail and XL nail is achieved using two tibial screws, two calcaneal screws and one talar screw. Holes in the nail allow for proximal and distal locking, using partially threaded cortical screws, 5 mm diameter, from 20 to 110 mm length.
NEWDEAL
511110ND
In Commercial Distribution
- M248511110ND1 ()
- 10381780051022 ()
- 5.0mm diam. x 110mm length
511110ND
- Orthopaedic bone screw, non-bioabsorbable, sterile