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4.5mm Occipital Screw, 13mm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-31-4513
Not in Commercial Distribution
- 10889981034177 ()
- 4.5mm, 13mm
16-31-4513
- Bone-screw internal spinal fixation system, non-sterile
SmartMTA is an ideal material for vital pulp therapy and root repair. With a setting time of 150 seconds and no washout, it is ideal for one-visit treatment. SmartMTA contains no heavy metals and will not discolor after application. SmartMTA has a wide variety of clinical indications such as partial and complete pulpotomy for deciduous teeth, direct and indirect pulp capping, base formation, root repair and prevention of discoloration when used for tooth whitening procedures.
BioMTA
SmMTA-10
In Commercial Distribution
- 08800027200023 ()
- Endodontic filling/sealing material
The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided), transported appropriately to the lab and analyzed with validated qRT-PCR assays for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans.
Manufacturers Note: Under enforcement discretion, we are currently exempt of having 510(k) during emergency and threat of Covid.
BIO-MED DIAGNOSTICS, INC.
1602
In Commercial Distribution
- B08816026 ()
- B08816020 ()
- B08816021 ()
11-602-001
- Viral transport medium IVD
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 Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model LN and L. The device description of the Dental Low-speed Handpiece is as following:
The gear ratios of handpieces have various gear ratios (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));
The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.
The air motors are capable of running up to a speed of 22000 rpm, but different at different pressure of air supply; refer to section 2.3 for details.
The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
Guangdong JINME Medical Technology Co., Ltd.
LN, L
In Commercial Distribution
- 06971119540029 ()
- Dental power tool system handpiece, pneumatic
Electrode conductive pad
A small, non-sterile device designed to facilitate electrical conduction between an electrical stimulation electrode and the skin.
It is typically contoured to fit on a particular type of electrode and is made of an absorbent material (e.g., felt)
that may be soaked in a conduction fluid.
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
TKF5050
In Commercial Distribution
- 04719871183489 ()
- Electrical probe/electrode conductive pad
The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445060
In Commercial Distribution
- 00842768004407 ()
- 00630414009759 ()
CBHCG
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
Restorative Posture Device with pads. Orthosis device used in conjunction with AMPCARE's Effective Swallowing Protocol (ESP) to enhance swallowing treatment by assisting with proper position of head and neck, maintaining placement and improving electrical conduction of E Series Electrodes and providing a resistive exercise protocol. For single patient use.
AMPCARE, LLC
RPD
In Commercial Distribution
- 00867786000231 ()
50707
- Cervicothoracic spine orthosis
A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esophageal schinctor. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen and wire-guided. This is a single-use device.
HOBBS MEDICAL, INC.
3306
In Commercial Distribution
- M84933060 ()
3306
- Oesophageal balloon catheter
A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esophageal schinctor. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen and wire-guided. This is a single-use device.
HOBBS MEDICAL, INC.
3304
In Commercial Distribution
- M84933040 ()
3304
- Oesophageal balloon catheter