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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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alpHaONE - 06946332804173

pH capsule
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPC-1
In Commercial Distribution

  • 16946332804170 ()
  • 06946332804173 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible

alpHaONE - 06946332800649

Data recorder
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPR-3
In Commercial Distribution

  • 06946332800649 ()
  • 16946332803159 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible

alpHaONE - 06946332800045

pH capsule, 1 pack
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPC-1
In Commercial Distribution

  • 06946332800625 ()
  • 06946332800045 ()
  • 06946332800632 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible

BOND - 09349458005535

The BOND-ADVANCE Controller provides the computer that contains the software (version 7.0) that controls the Processing Module(s).Used in BOND multi seat configurations.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND-ADVANCE Controller (7.0)
In Commercial Distribution

  • 09349458005535 ()
49.4526

  • Microscope slide stainer IVD

BOND - 09349458005474

The BOND-ADVANCE Controller provides the computer that contains the software (version 6.0) that controls the Processing Module(s). Used in BOND multi seat configurations.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND-ADVANCE Controller (6.0)
In Commercial Distribution

  • 09349458005474 ()
S21.4623

  • Microscope slide stainer IVD

VibroTactile - 00718175004302

VIBROTACTILE BELT KIT
BIODEX MEDICAL SYSTEMS, INC.
950-430
In Commercial Distribution

  • 00718175004302 ()


  • Posturography system

BIOSWAY - 00718175000120

BIOSWAY PORTABLE BAL SYS w/CASE
BIODEX MEDICAL SYSTEMS, INC.
950-460
In Commercial Distribution

  • 00718175000120 ()
950-460

  • Posturography system

BALANCE SD - 00718175000052

Balance System SD, 100 VAC
BIODEX MEDICAL SYSTEMS, INC.
950-444
In Commercial Distribution

  • 00718175000052 ()
950-444

  • Posturography system

BALANCE SD - 00718175000038

Balance System SD, 115 VAC
BIODEX MEDICAL SYSTEMS, INC.
950-440
In Commercial Distribution

  • 00718175000038 ()
950-440

  • Posturography system

BALANCE SD - 00718175000045

Balance System SD, 230 VAC
BIODEX MEDICAL SYSTEMS, INC.
950-441
In Commercial Distribution

  • 00718175000045 ()
950-441

  • Posturography system
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