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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JAPAN TI 5.5MM TELESCOPING BRIDGE, 65MM
ALPHATEC SPINE, INC.
62402
In Commercial Distribution

  • 00844856004979 ()

  • Outer Diameter: 5.5 Millimeter
  • Height: 65 Millimeter


  • Bone-screw internal spinal fixation system connector
JAPAN TI 5.5MM TELESCOPING BRIDGE, 45MM
ALPHATEC SPINE, INC.
62401
In Commercial Distribution

  • 00844856004962 ()

  • Outer Diameter: 5.5 Millimeter
  • Height: 45 Millimeter


  • Bone-screw internal spinal fixation system connector
PerforMax Disposable SE SA, Japan, Small
Respironics, Inc.
00
In Commercial Distribution

  • 30606959011862 ()
  • 00606959011861 ()
1055002

  • CPAP/BPAP face mask, single-use
FitLife Mask with Headgear, Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, Large, Japan
Not in Commercial Distribution

  • 00606959023031 ()
1060806

  • CPAP/BPAP face mask, reusable
FitLife Mask with Headgear, Small, Japan
Respironics, Inc.
FitLife Mask with Headgear, Small, Japan
Not in Commercial Distribution

  • 00606959023024 ()
1060805

  • CPAP/BPAP face mask, reusable
BiPAP Hybrid A30 Ventilator, SpO2, Japan
Respironics, Inc.
BiPAP Hybrid A30 Ventilator, SpO2, JP
Not in Commercial Distribution

  • 00606959038134 ()
1111153

  • Portable electric ventilator
DreamStation Cellular Modem with Oximetry, Japan
Respironics, Inc.
DreamStation, Cellular Modem with Oximetry, JP
Not in Commercial Distribution

  • 00606959037540 ()
200630C

  • Medical networking interface unit
Trilogy 100 Ventilator, Recertified, Japan version
Respironics, Inc.
00
In Commercial Distribution

  • 00606959033955 ()
U1054655

  • Portable electric ventilator
Trilogy 200 Ventilator, Rental, Japan version
Respironics, Inc.
Trilogy 200 Ventilator, Japan-Rental
Not in Commercial Distribution

  • 00606959033863 ()
R1032804

  • Portable electric ventilator
Alice 6 Base Station, LDx, Japan
Respironics, Inc.
Alice 6 Base Station, LDx, Japan
Not in Commercial Distribution

  • 00606959033764 ()
JP1063315

  • Polysomnograph
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