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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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MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020269 ()
901610-202

  • Fully-implantable middle ear implant system
Sound Processor Model 2001, IS-1 Connector Ports
Envoy Medical Corporation
2001
In Commercial Distribution

  • 00812282020214 ()
902001-003

  • Fully-implantable middle ear implant system
Esteem® Commander™ Model 6001
Envoy Medical Corporation
6001
In Commercial Distribution

  • 00812282020122 ()
906011-102

  • Fully-implantable middle ear implant system
Personal Programmer Model 8001
Envoy Medical Corporation
8001
In Commercial Distribution

  • 00812282020078 ()
908001-101

  • Fully-implantable middle ear implant system
Sensor Model 7004, IS-1 Connector
Envoy Medical Corporation
7004
In Commercial Distribution

  • 00812282020054 ()
907004-003

  • Fully-implantable middle ear implant system
Sensor Model 7004, IS-1 Connector
Envoy Medical Corporation
7004
In Commercial Distribution

  • 00812282020047 ()
907004-001

  • Fully-implantable middle ear implant system
Driver Model 7510, IS-1 Connector
Envoy Medical Corporation
7510
In Commercial Distribution

  • 00812282020030 ()
907510-001

  • Fully-implantable middle ear implant system
Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020023 ()
907504-003

  • Fully-implantable middle ear implant system
Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020016 ()
907504-001

  • Fully-implantable middle ear implant system
Sensor Model 7010, IS-1 Connector
Envoy Medical Corporation
7010
In Commercial Distribution

  • 00812282020009 ()
907010-001

  • Fully-implantable middle ear implant system
Esteem® Commander™ Model 6002
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020498 ()
906002-001

  • Fully-implantable middle ear implant system
EnvoyCem® Glass Ionmer Cement
Envoy Medical Corporation
1640
In Commercial Distribution

  • 00812282020375 ()
901640-103

  • Glass ionomer dental cement
MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020276 ()
901610-203

  • Fully-implantable middle ear implant system
MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020252 ()
901610-003

  • Fully-implantable middle ear implant system
Sound Processor Model 2001, IS-1 Connector Ports
Envoy Medical Corporation
2001
In Commercial Distribution

  • 00812282020207 ()
902001-002

  • Fully-implantable middle ear implant system
Wheelchair mechanical
Motion Composites Inc
Apex C
In Commercial Distribution

  • 00811774000086 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible
Wheelchair mechanical
Motion Composites Inc
Helio A6
In Commercial Distribution

  • 00811774000062 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
wheelchair mechanical
Motion Composites Inc
Veloce
In Commercial Distribution

  • 00811774000024 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Wheelchair mechanical
Motion Composites Inc
Apex A
In Commercial Distribution

  • 00811774000079 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible
wheelchair mechanical
Motion Composites Inc
Helio C2
In Commercial Distribution

  • 00811774000031 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
wheelchair mechanical
Motion Composites Inc
Helio A7
In Commercial Distribution

  • 00811774000017 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
NEEDLE SPINAL S/SU 20GA 3-1/2IN QUINCKE
BECTON, DICKINSON AND COMPANY
405182
In Commercial Distribution

  • 50382904051827 ()
  • 00382904051822 ()
  • 30382904051823 ()

  • Length: 3.5 Inch
405182

  • Spinal needle, single-use
NEEDLE SPINAL S/SU 22GA 3-1/2IN QUINCKE
BECTON, DICKINSON AND COMPANY
405181
In Commercial Distribution

  • 50382904051810 ()
  • 00382904051815 ()
  • 30382904051816 ()

  • Length: 3.5 Inch
405181

  • Spinal needle, single-use
  • Evacuated blood collection tube IVD, anticoagulant/antiglycolytic
NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
BECTON, DICKINSON AND COMPANY
405180
In Commercial Distribution

  • 50382904051803 ()
  • 00382904051808 ()
  • 30382904051809 ()

  • Length: 3.5 Inch
405180

  • Spinal needle, single-use
TUBING WITH T-PIECE WITH LUER CAP
Intersurgical Incorporated
9451830
In Commercial Distribution

  • 05030267091256 ()
  • 05030267086986 ()


  • Gas-sampling/monitoring respiratory tubing, single-use
SonoVision Accessory Kit
Tissue Differentiation Intelligence LLC
100039
In Commercial Distribution

  • 00860001239300 ()


  • Interventional radiology percutaneous-access kit, reusable
Depth Sensor
Foresite Healthcare, LLC
DS6-DB
In Commercial Distribution

  • 00850064651102 ()


  • Biomechanical function analysis system, motion-tracking
Bed Sensor
Foresite Healthcare, LLC
Bed4-UBS
In Commercial Distribution

  • 00850064651096 ()


  • Bed/chair occupant movement pressure/vibration sensor
Bed Sensor
Foresite Healthcare, LLC
Bed4-RPS
In Commercial Distribution

  • 00850064651089 ()


  • Bed/chair occupant movement pressure/vibration sensor
Bed Sensor
Foresite Healthcare, LLC
Bed4-UB
In Commercial Distribution

  • 00850064651072 ()


  • Bed/chair occupant movement pressure/vibration sensor
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