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 REDUCED KEEL INSTRUMENTATION #3/#4 CEMENT TIBIAL PUNCH
Howmedica Osteonics Corp.
3761-0304
In Commercial Distribution

  • 07613327222777 ()

  • Size: 4
  • Size: 3
3761-0304

  • Orthopaedic prosthesis implantation positioning instrument, reusable
JAPAN KNEE INSTRUMENTATION #5/#6 PRESS FIT TIBIAL PUNCH
Howmedica Osteonics Corp.
3760-0506
In Commercial Distribution

  • 07613327222654 ()

  • Size: 6
  • Size: 5
3760-0506

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SWMD DLIR Application for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.2
In Commercial Distribution

  • 00195278620453 ()
5928863

  • CT system application software
MAR Application Container for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.1
In Commercial Distribution

  • 00195278303219 ()


  • CT system application software
DLIR Application Container for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.1
In Commercial Distribution

  • 00195278303202 ()


  • CT system application software
ASiR-V Application Container for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.1
In Commercial Distribution

  • 00195278303196 ()


  • CT system application software
Ascend Select Gantry common top asm with UDI
GE HEALTHCARE JAPAN CORPORATION
Ascend Select
In Commercial Distribution

  • 00195278718204 ()
RevolutionAscendSelect

  • Full-body CT system
Ascend Plus Gantry common top asm with UDI
GE HEALTHCARE JAPAN CORPORATION
Ascend Plus
In Commercial Distribution

  • 00195278718136 ()
RevolutionAscendPlus

  • Full-body CT system
Ascend Elite Gantry common top asm with UDI
GE HEALTHCARE JAPAN CORPORATION
Ascend Elite
In Commercial Distribution

  • 00195278718129 ()
RevolutionAscendElite

  • Full-body CT system
No Description
GE HEALTHCARE JAPAN CORPORATION
M6C
In Commercial Distribution

  • 00840682110761 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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