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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ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution

  • 07290114064071 ()
407-000024-00

  • Brain-responsive electrical stimulation system
Packaged OptiMAX Software
Ototronix, LLC
M6102
In Commercial Distribution

  • M737M61021 ()


  • Partially-implantable middle ear implant system
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
ASC Legacy™ 5.7mm-Compatible Titanium Blank
Preat Corporation
9008565
In Commercial Distribution

  • 00842092183229 ()
9008565

  • Dental implant suprastructure, permanent, preformed
ASC Legacy™ 4.5mm-Compatible Titanium Blank
Preat Corporation
9007565
In Commercial Distribution

  • 00842092183212 ()
9007565

  • Dental implant suprastructure, permanent, preformed
ASC Straumann® BLX-compatible WB Titanium Blank
Preat Corporation
9007265
In Commercial Distribution

  • 00842092183205 ()
9007265

  • Dental implant suprastructure, permanent, preformed
ASC Neodent® GM™ compatible Titanium Blank
Preat Corporation
9007165
In Commercial Distribution

  • 00842092183199 ()
9007165

  • Dental implant suprastructure, permanent, preformed
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