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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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zLOCK tools Tray #3 - 07290019421146

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

  • 07290019421146 ()


  • Spinal bone screw, non-bioabsorbable

zLOCK tools Tray #2 - 07290019421139

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

  • 07290019421139 ()
ZFT-100

  • Spinal bone screw, non-bioabsorbable

zLOCK tools Tray #1 - 07290019421122

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

  • 07290019421122 ()
ZFT-100

  • Spinal bone screw, non-bioabsorbable

Esteem® Commander™ - 00812282020504

Esteem® Commander™ Software Version 3.0
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020504 ()
006002-002

  • Fully-implantable middle ear implant system

Esteem® Commander™ - 00812282020481

Esteem® Commander™ Software Version 2.2
Envoy Medical Corporation
6001
In Commercial Distribution

  • 00812282020481 ()
003873-010

  • Fully-implantable middle ear implant system

Esteem® Intraoperative System Analyzer - 00812282020429

Intraoperative System Analyzer (ISA), Software Version 9.0
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020429 ()
004652-005

  • Fully-implantable middle ear implant system

Esteem® Intraoperative System Analyzer - 00812282020160

Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020160 ()
903001-003

  • Fully-implantable middle ear implant system

OT EQUATOR-OT BRIDGE - 08059224047171

STERILIZABLE stainless steel device. To be connected to the blue handle for insertion tools.
RHEIN 83 SRL
METAL INSERTION TOOL FOR SEEGER
In Commercial Distribution

185SIS

  • Dental implant suprastructure, permanent, preformed

Eversense DMS Pro - 00817491023513

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-5905-01-300
In Commercial Distribution

  • 00817491023513 ()
FG-5905-01-300

  • Implantable glucose monitoring system

Eversense DMS - 00817491023506

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-5705-01-300
In Commercial Distribution

  • 00817491023506 ()
FG-5705-01-300

  • Implantable glucose monitoring system
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