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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 140 mm stent preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.
ENDO GI MEDICAL LTD
Single-Stent (140mm)
In Commercial Distribution

  • 00860005738236 ()

  • Stent Length: 140 Millimeter


  • Polymeric biliary stent, non-bioabsorbable
The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 80 mm stent preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.
ENDO GI MEDICAL LTD
Single-Stent (80mm)
In Commercial Distribution

  • 00860005738229 ()

  • Stent Length: 80 Millimeter


  • Polymeric biliary stent, non-bioabsorbable
The EndoGI S-Path Pre-loaded RX Biliary Stent System is designed for the deployment of the EndoGI Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI S-Path Pre-loaded RX Biliary Stent System is available in 10Fr and is supplied with one 110 mm stent preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.
ENDO GI MEDICAL LTD
Single-Stent
In Commercial Distribution

  • 10860005738219 ()
  • 00860005738212 ()

  • Stent Length: 110 Millimeter


  • Polymeric biliary stent, non-bioabsorbable
The EndoGI X-Path Pre-loaded RX-OTW Double Biliary Stents System is designed for the deployment of the EndoGI Biliary stent(s) enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The stent, made of a radiopaque polymer consists of a tapered proximal end and is endoscopically visible. The EndoGI Delivery System enables insertion and placement of two stents in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site. The EndoGI Biliary Stent System is available in 10Fr and is supplied with two 110 mm stents preloaded on the Delivery System. A stent barb cover is provided to facilitate placement of the stent into the endoscope.
ENDO GI MEDICAL LTD
Double-Stent
In Commercial Distribution

  • 00860005738205 ()
  • 10860005738202 ()

  • Stent Length: 110 Millimeter


  • Polymeric biliary stent, non-bioabsorbable
Body composition scale. 200kg model.
LEXINGTON WELLNESS HOLDINGS INC.
S-5 (200kg)
In Commercial Distribution

  • 10860005561732 ()
  • 00860005561735 ()


  • Bioelectrical body composition analyser
The NightWare device includes a software application and the NightWare server. The device uses an Apple Watch® and an Apple iPhone® for its platform. These components monitor your sleep behavior and, using a proprietary formula, creates a unique sleep profile to help you get a better night’s sleep. NightWare is designed to monitor your heart rate and movement throughout the night and occasionally provide vibrotactile interventions (haptic feedback) through the Apple Watch while you are sleeping. These interventions will occur when NightWare detects that you have exceeded a certain threshold and will disrupt the phenomena consistent with a nightmare at the time that it is occurring. The first night you use NightWare, the watch will not provide any of these interventions because it is gathering enough data to create your unique sleep profile. The data that NightWare collects from the Apple Watch includes: Heart Rate, Body Movement (Acceleration),Body Position (Rotation). This information is securely sent to the NightWare servers and processed to help you improve the quality of your sleep.
Nightware Incorporated
100001
In Commercial Distribution

  • 00860005400706 ()


  • Sleep disorder interpretive software, patient-use
The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor’s office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user’s clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).
Spark Biomedical Inc.
11-320-K
In Commercial Distribution

  • 00860005396986 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain. This is a subcomponent and is not transacted. See 810-P.
Spark Biomedical Inc.
810
In Commercial Distribution

  • 00860005396979 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes.
Spark Biomedical Inc.
210
In Commercial Distribution

  • 00860005396962 ()
  • 00860005396993 ()
  • 00850052017064 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. This is a subcomponent and is not transacted. See 11-110-K.
Spark Biomedical Inc.
110
In Commercial Distribution

  • 00860005396955 ()


  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
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