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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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SYNVISC (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. SYNVISC is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
SAIMA GLOBAL FARMA S.L.
58468-0090-1
In Commercial Distribution

  • 08437027710056 ()
  • 08437027710032 ()


  • Synovial fluid supplementation medium
The MARGINPROBE System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (less than 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
DILON MEDICAL TECHNOLOGIES LTD
SA0590020
In Commercial Distribution

  • 07290012534058 ()


  • Intraoperative tumour margin analysis probe
The Model 1620 AC Recharger is a non-sterile external power supply that connects to a power outlet for use in charging the battery within the Mobile Charger.
Reshape Lifesciences Inc.
1620
Not in Commercial Distribution

  • 00857334004200 ()

  • Length: 9.5 Inch
1620

  • Noninvasive device battery charger
Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5600-01-300
Not in Commercial Distribution

  • 00817491020826 ()
FG-5600-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5500-01-300
Not in Commercial Distribution

  • 00817491020819 ()
FG-5500-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution

  • 00817491023605 ()
FG-5501-01-300

  • Implantable glucose monitoring system
Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-01-300
Not in Commercial Distribution

  • 00817491022370 ()
FG-5501-01-300

  • Implantable glucose monitoring system
SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).
SALIX PHARMACEUTICALS, LTD.
1085003
In Commercial Distribution

  • 00365649850035 ()
  • 10365649850032 ()


  • Anal tissue reconstructive material
XVIVO Lung Cannula Set™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment.
Xvivo Perfusion AB
19022
In Commercial Distribution

  • 07350069520098 ()
19022

  • Lung donor-organ preservation/evaluation system lung-interface set
Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution

  • 00817491023612 ()
FG-5502-01-300

  • Implantable glucose monitoring system
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