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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Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronics and software.
Canary Medical USA LLC
43-5570-030-14
In Commercial Distribution

  • 00860003118399 ()


  • Knee femur stem prosthesis
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
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
Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
BONE SOLUTIONS, INC.
15cc
In Commercial Distribution

  • B4477121150 ()
712115

  • Bone matrix implant, synthetic, non-antimicrobial
Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4477121100 ()
712110

  • Bone matrix implant, synthetic, non-antimicrobial
Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
BONE SOLUTIONS, INC.
5cc
In Commercial Distribution

  • B4477121050 ()
712105

  • Bone matrix implant, synthetic, non-antimicrobial
Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
BONE SOLUTIONS, INC.
15cc
In Commercial Distribution

  • B4477120150 ()
712015

  • Bone matrix implant, synthetic, non-antimicrobial
Opus Mg Set BVF is an injectable, moldable, and biocompatible Bone Void Filler. Opus Mg Set BVF Packet contains powder (Magnesium based compound) and a mixing solution (Buffered saline). It is a sterile, single use device, packaged with mixing and administration tools.
BONE SOLUTIONS, INC.
10cc
In Commercial Distribution

  • B4477120100 ()
712010

  • Bone matrix implant, synthetic, non-antimicrobial
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