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Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14153
In Commercial Distribution
- B091141531 ()
- B091141530 ()
- Outer Diameter: 16 Millimeter
14153
- Orbital sphere implant
Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14153
In Commercial Distribution
- B091141530 ()
- Outer Diameter: 16 Millimeter
14153
- Orbital sphere implant
Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14152
In Commercial Distribution
- B091141521 ()
- B091141520 ()
- Outer Diameter: 14 Millimeter
14152
- Orbital sphere implant
Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14152
In Commercial Distribution
- B091141520 ()
- Outer Diameter: 14 Millimeter
14152
- Orbital sphere implant
Automatrix Snippers+ Catch Tray is a part of the Automatrix Snippers+ to prevent clipped loop pieces rom the oral cavity.
Dentsply De Trey GmbH
62422605
In Commercial Distribution
- D010624226050 ()
- D010624226051 ()
- Length: 1.9 Centimeter
62422605
- Orthodontic pliers
The capsule is a physiologic battery-powered device used for gastric monitoring and data collection. The tethered pH capsule is swallowed by the patient. The information gathered by the capsule contains one or more gastric parameters (i.e., pH, events and or gastric bleeding, delayed stomach emptying, or gastric dumping). The capsule is comprised of a sensor for monitoring gastric pH and movement. The telemetric signals produced by the pH capsule are detected by the patient worn transceiver. The capsules data is transmitted from the transceiver to the Heidelberg Interface module. The interface module sends the capsule information to the computer. The computer software interprets the capsule data and displays it on computer generated graph. This is a single-use device.
Heidelberg Medical Inc
Heidelberg pH Telemetric Capsules
In Commercial Distribution
- B989HTC1020 ()
HTC102
- Gastrointestinal telemetric monitoring system capsule, ingestible
The Integra DigiFuse Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options. A 2.0mm x 0° mini-blade is also offered for DIP fusions and smaller anatomy. The system includes instruments to facilitate the placement of the implants. All implants are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
Ascension Orthopedics, Inc.
DIGIFUSEIMP2
Not in Commercial Distribution
- M268DIGIFUSEIMP21 ()
- 10381780074281 ()
DIGIFUSEIMP2
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
SELF-ETCH (SE) BONDING AGENT is indicated for the bonding of direct composite, resin modified glass ionomers or compomers to dentin/enamel. SE BONDING AGENT is a self-etch, light-cure one component adhesive resin system designed to bond composites to enamel and dentin. It is a quick and easy way to bond composites to the tooth. SE BONDING AGENT provides "all in one": etching of, priming of and adhesion to enamel and dentin. This system is responsive to any dental curing light; the curing times can vary with the radiance of the light source. SE Bonding Agent is a dimethacrylate based bonding system with photosynthesizers. Instructions for use and SDS available at https://www.scottsdental.com/select-plus-bond.html
SCOTT'S DENTAL SUPPLY L.L.C.
199-1050
In Commercial Distribution
- D77819910500 ()
- Total Volume: 5 Milliliter
199-1050
- Dentine bonding agent/set
The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System
analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during
sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders,
where it may inform or drive clinical management for children, adolescents and adults.
The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare
professionals in diagnosis and management of sleep disordered breathing.
The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified
healthcare professional.
MYCARDIO LLC
2
In Commercial Distribution
- B315SLEEPIMAGESYSTEMD8 ()
- Sleep disorder interpretive software, professional-only
The Instrumentation Industries, Inc. RTC 24-V KIT includes the RTC 24-V MDI Adapter actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V KIT is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V KIT is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V KIT is Critical Care and/or long term or short term ventilation.
The components of the RTC 24-V KIT consist of one RTC 24-V MDI Adapter, one four inch length of 22mm inner-diameter tubing, and one 15mm inner-diameter/22mm outer-diameter adapter.
The RTC 24-V KIT is intended for single patient reuse.
This device is intended for sale by or on the order of a physician.
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 24-V Kit
In Commercial Distribution
- M996RTC24VKIT0 ()
- M996RTC24VKIT2 ()
- Metered dose inhaler