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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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Lumicell Direct Visualization System (DVS) - 00860003252543

Workstation Assembly
Lumicell, Inc.
810-00217
In Commercial Distribution

  • 00860003252543 ()
  • 00860008537805 ()


  • Intraoperative tumour margin fluorescence imaging system

Lumicell Direct Visualization System (DVS) - 00860003252536

Light source
Lumicell, Inc.
810-00212
In Commercial Distribution

  • 00860003252598 ()
  • 00860003252536 ()


  • Intraoperative tumour margin fluorescence imaging system

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

Ceiba - 00860006137014

Brand-independent integration with Ceiba eConnect APIs of medical devices (monitors, respirators, pumps, blood gas) and hospital systems
Ceiba Healthcare Technologies LLC
ECONNECT IoMT Box
In Commercial Distribution

  • 00860006137014 ()


  • Medical networking interface unit
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