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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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Scopis ENT Software with Target Guided Surgery
Stryker Leibinger GmbH & Co. KG
8000-020-002
In Commercial Distribution

  • 07613327413199 ()
8000-020-002

  • Stereotactic system application software
Clinician Programmer Software for H200 Wireless System
Bioness Medical, Inc.
H2W-SW01
In Commercial Distribution



  • Hand orthosis
Clinician Programmer Software for L300 Go System
Bioness Medical, Inc.
LG4-SW01
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
Zvu® Functional GI Software Revision 3.4.0
DIVERSATEK HEALTHCARE, INC.
ZVU-3 Revision 3.4.0
In Commercial Distribution

  • 00816734023426 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system
GoCheck Kids Native Software Application for Nokia.
Gobiquity, Inc.
Nokia 4.6.3
In Commercial Distribution

GCKNOK463

  • External ocular measurement camera
Clinician Programmer Software for L300 Go system
BIONESS INC.
LG4-SW01
In Commercial Distribution

  • 00815962020061 ()


  • Gait-enhancement electrical stimulation system, external
Esteem® Commander™ Software Version 3.0
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020504 ()
006002-002

  • Fully-implantable middle ear implant system
Esteem® Commander™ Software Version 2.2
Envoy Medical Corporation
6001
In Commercial Distribution

  • 00812282020481 ()
003873-010

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Software Version 9.0
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020429 ()
004652-005

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020160 ()
903001-003

  • Fully-implantable middle ear implant system
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