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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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GN Hearing - 05708296174904

KIT,PROG,SUPER POWER,LO90
Gn Hearing A/S
19215000
In Commercial Distribution

  • 05708296174904 ()


  • Hearing aid/implant system functionality-enhancing device

Visix - 00851800007092

Visix software for use with just an intraoral camera version 2.3.10
TELEVERE SYSTEMS, LLC
for Intraoral Camera 2.3.10
In Commercial Distribution

  • 00851800007092 ()
Visix for Intraoral Camera 2.3.10

  • Camera application software
  • Radiological PACS software

GN Hearing - 05708296233618

DAI SHOE,ASM,C80R,PKG
Gn Hearing A/S
21520400
In Commercial Distribution

  • 05708296233618 ()


  • Hearing aid/implant system functionality-enhancing device

IDENTIFY - 00858086006818

No Description
VARIAN MEDICAL SYSTEMS, INC.
4.0
In Commercial Distribution

  • 00858086006818 ()


  • Real-time position management respiratory gating system, optical

IDENTIFY - 00858086006801

No Description
VARIAN MEDICAL SYSTEMS, INC.
3.0
In Commercial Distribution

  • 00858086006801 ()


  • Real-time position management respiratory gating system, optical

Varian RPM Gating Marker Block (6 Dot) - 00858086006627

No Description
VARIAN MEDICAL SYSTEMS, INC.
100025549-03
In Commercial Distribution

  • 10858086006624 ()
  • 00858086006627 ()


  • Real-time position management respiratory gating system, optical

Varian RPM Gating Marker Block (2 Dot) - 00858086006610

No Description
VARIAN MEDICAL SYSTEMS, INC.
1107081-02
In Commercial Distribution

  • 10858086006617 ()
  • 00858086006610 ()


  • Real-time position management respiratory gating system, optical

Varian RPM Gating Marker Block (6 Dot) - 00858086006399

No Description
VARIAN MEDICAL SYSTEMS, INC.
100025549-02
In Commercial Distribution

  • 10858086006396 ()
  • 00858086006399 ()
100025549-02

  • Real-time position management respiratory gating system, optical

Varian RPM Gating Marker Block (2 Dot) - 00858086006382

No Description
VARIAN MEDICAL SYSTEMS, INC.
1107081-01
In Commercial Distribution

  • 10858086006389 ()
  • 00858086006382 ()
1107081-01

  • Real-time position management respiratory gating system, optical

NA - 00851725007092

Communication Gateway Server CGS-9001 (Pager Commnunication Gateway Server)
Nihon Kohden Digital Health Solutions, LLC
CGS-9001
In Commercial Distribution

  • 00851725007092 ()
CGS-9001

  • Medical networking interface unit
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