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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
SAM is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin (Hgb) levels in hemodialysis patients. The device is intended to help clinicians manage chronic anemia.
Dosis Inc.
1
In Commercial Distribution

  • 00860005737512 ()


  • Nephrology information system application software
The NuVision Connector Cable is a non-sterile, reusable connector cable intended to connect the sterile, single-use NuVision ICE Catheter to a qualified GE ultrasound cardiac imaging system.
Biosense Webster Inc
FG10594
In Commercial Distribution

  • 00860005688111 ()
FG10594

  • Electrical-only medical device connection cable, reusable
The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use.
Biosense Webster Inc
FG10593
In Commercial Distribution

  • 00860005688104 ()
FG10593

  • Intracardiac ultrasound imaging catheter, steerable, single-use
The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that minimizes exposure of aerosols during ENT procedures.
Inquis Medical, Inc.
IB-1000
Not in Commercial Distribution

  • 00860005664009 ()


  • Patient examination/treatment drape, single-use
Clear Dental Aligner
Straight-T LLC
X
In Commercial Distribution

  • 00860005619016 ()


  • Orthodontic aligner auxiliary attachment kit
No Description
Overjet, Inc.
v1
In Commercial Distribution

  • 00860005586370 ()


  • Dental x-ray image interpretive software
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