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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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Eversense® DMS Pro - 00817491021885

The Eversense DMS Pro is a software intended for clinic use. Eversense DMS Pro can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5900-01-300
Not in Commercial Distribution

  • 00817491021885 ()
FG-5900-01-300

  • Implantable glucose monitoring system

Eversense® DMS - 00817491021878

Eversense DMS is a software intended for home use. Eversense DMS can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5700-01-300
Not in Commercial Distribution

  • 00817491021878 ()
FG-5700-01-300

  • Implantable glucose monitoring system

zLOCK tools Trays #1+ #3 - 07290019421160

The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
ZYGOFIX LTD
1
In Commercial Distribution

  • 07290019421160 ()
ZFT-100

  • Spinal bone screw, non-bioabsorbable

zLOCK tools Trays #1+ #2 - 07290019421153

The zLOCK Lumbar Facet Fixation System is a modular facet screw system for posterior lumbar spinal stabilization. The zLOCK Lumbar Facet Fixation System consists of two main components: 1) a Facet Screw with a washer and 2) a Modular spacer. The system including a dedicated tool set, contained in dedicated trays that are marked with UDI.
ZYGOFIX LTD
1
In Commercial Distribution

  • 07290019421153 ()
ZFT-100

  • Spinal bone screw, non-bioabsorbable

HVAD® Pump Surgical Tools - 00888707008204

No Description
Heartware Inc.
1318
In Commercial Distribution

  • 00888707008204 ()
1318

  • Implantable ventricular circulatory assist system

HVAD® Pump Surgical Tools - 00888707005388

No Description
Heartware Inc.
MCS1718ST
In Commercial Distribution

  • 00888707005388 ()
MCS1718ST

  • Implantable ventricular circulatory assist system

HVAD® Pump Surgical Tools - 00888707000185

No Description
Heartware Inc.
1317
Not in Commercial Distribution

  • 00888707000185 ()
1317

  • Implantable ventricular circulatory assist system

HVAD® Pump Surgical Tools - 00888707000154

No Description
Heartware Inc.
1318
Not in Commercial Distribution

  • 00888707000154 ()
1318

  • Implantable ventricular circulatory assist system

MINT - 08809556174454

No Description
Hans Biomed Corp.
MINT lift ML 1043
In Commercial Distribution

  • 08809556174454 ()
  • 18809556174451 ()


  • Lift thread, bioabsorbable

MINT - 08809556174447

No Description
Hans Biomed Corp.
MINT lift MINI-S 1017
In Commercial Distribution

  • 08809556174447 ()
  • 18809556174444 ()


  • Lift thread, bioabsorbable
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