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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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DIGITAL SWALLOWING CABLE
PENTAX OF AMERICA, INC.
7184-5900
In Commercial Distribution

  • 04961333231386 ()


  • Manometric gastrointestinal motility analysis system
THREE BULB ARRAY
PENTAX OF AMERICA, INC.
7181-9900
In Commercial Distribution

  • 04961333231362 ()


  • Manometric gastrointestinal motility analysis system
TWO BULB ARRAY
PENTAX OF AMERICA, INC.
7181-9800
In Commercial Distribution

  • 04961333231355 ()


  • Manometric gastrointestinal motility analysis system
EMG CABLE,6' (1250-0334)
PENTAX OF AMERICA, INC.
7180-2102
In Commercial Distribution

  • 04961333231348 ()

  • Length: 6.0 Feet


  • Manometric gastrointestinal motility analysis system
SYNC MODULE FOR PAL 230V
PENTAX OF AMERICA, INC.
7127E
Not in Commercial Distribution

  • 04961333231317 ()


  • Manometric gastrointestinal motility analysis system
SWALLOWING UPGRADE
PENTAX OF AMERICA, INC.
7120B-2
Not in Commercial Distribution

  • 04961333231300 ()


  • Manometric gastrointestinal motility analysis system
MONITOR, ACER V196L 19" LCD
PENTAX OF AMERICA, INC.
1111-1420
In Commercial Distribution

  • 04961333231171 ()


  • Manometric gastrointestinal motility analysis system
EMG CABLE,6' (1250-0335)
PENTAX OF AMERICA, INC.
7180-2101
In Commercial Distribution

  • 04961333231331 ()

  • Length: 6.0 Feet


  • Manometric gastrointestinal motility analysis system
ANALOG-DIGITAL CONVERT DFG/SV1
PENTAX OF AMERICA, INC.
1111-1582
In Commercial Distribution

  • 04961333231188 ()


  • Manometric gastrointestinal motility analysis system
SYNC MODULE FOR FULL SYSTEM
PENTAX OF AMERICA, INC.
7127
Not in Commercial Distribution

  • 04961333231089 ()


  • Manometric gastrointestinal motility analysis system
TONGUE HARDWARE W/25 ARRAYS
PENTAX OF AMERICA, INC.
7124
In Commercial Distribution

  • 04961333231072 ()


  • Manometric gastrointestinal motility analysis system
Tongue Arrays
PENTAX OF AMERICA, INC.
7183-4500
In Commercial Distribution

  • 04961333230495 ()
  • 34961333230496 ()


  • Manometric gastrointestinal motility analysis system
Tongue Arrays
PENTAX OF AMERICA, INC.
7179-0040
In Commercial Distribution

  • 04961333230464 ()
  • 34961333230465 ()


  • Manometric gastrointestinal motility analysis system
Tongue Arrays
PENTAX OF AMERICA, INC.
7179-0035
In Commercial Distribution

  • 04961333230457 ()
  • 34961333230458 ()


  • Manometric gastrointestinal motility analysis system
Nasal Cannulas
PENTAX OF AMERICA, INC.
7179-0030
In Commercial Distribution

  • 04961333230440 ()
  • 14961333230446 ()


  • Manometric gastrointestinal motility analysis system
Electrodes
PENTAX OF AMERICA, INC.
7179-0025
In Commercial Distribution

  • 04961333230433 ()
  • 14961333230439 ()


  • Manometric gastrointestinal motility analysis system
Electrodes
PENTAX OF AMERICA, INC.
7179-0020
In Commercial Distribution

  • 04961333230426 ()
  • 14961333230422 ()


  • Manometric gastrointestinal motility analysis system
Laryngeal Microphone
PENTAX OF AMERICA, INC.
7126
In Commercial Distribution

  • 04961333229956 ()


  • Manometric gastrointestinal motility analysis system
Nasal Cannulas
PENTAX OF AMERICA, INC.
7125
In Commercial Distribution

  • 04961333229949 ()
  • 14961333229945 ()


  • Manometric gastrointestinal motility analysis system
Manometry Sensors (Gaeltec)
PENTAX OF AMERICA, INC.
7123
In Commercial Distribution

  • 04961333229932 ()


  • Manometric gastrointestinal motility analysis system
EMG Transducers (two channel)
PENTAX OF AMERICA, INC.
7122
In Commercial Distribution

  • 04961333229925 ()


  • Manometric gastrointestinal motility analysis system
100cc Syringe, Luer-Locking, 5-Pack
MEDSPIRA, LLC
RMD-010-017
In Commercial Distribution

  • 10851607003539 ()
  • 00851607003532 ()


  • Manometric gastrointestinal motility analysis system
Battery for Tablet PC
MEDSPIRA, LLC
RMD-010-009
In Commercial Distribution

  • 00851607003525 ()
  • 10851607003522 ()


  • Manometric gastrointestinal motility analysis system
Syringe, Luer-Locking, 100cc, 5-Pack
MEDSPIRA, LLC
RMD-010-016
In Commercial Distribution

  • 10851607003515 ()
  • 00851607003518 ()


  • Manometric gastrointestinal motility analysis system
AC Power Cable, 3-Prong, US
MEDSPIRA, LLC
RMD-010-003
In Commercial Distribution

  • 10851607003492 ()
  • 00851607003495 ()


  • Manometric gastrointestinal motility analysis system
mcompass Anorectal Manometry System
MEDSPIRA, LLC
RMD-001U
In Commercial Distribution

  • 10851607003393 ()
  • 00851607003396 ()


  • Manometric gastrointestinal motility analysis system
Accessories for mcompass systems
MEDSPIRA, LLC
RMD-010-011
In Commercial Distribution

  • 10851607003386 ()
  • 00851607003389 ()


  • Manometric gastrointestinal motility analysis system
Medspira Tablet PC with Power Supply
MEDSPIRA, LLC
RMD-010-010
In Commercial Distribution

  • 10851607003379 ()
  • 00851607003372 ()


  • Manometric gastrointestinal motility analysis system
Battery for FOB
MEDSPIRA, LLC
RMD-010-009
In Commercial Distribution

  • 10851607003362 ()
  • 00851607003365 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-004
In Commercial Distribution

  • 10851607003317 ()
  • 00851607003310 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-008
In Commercial Distribution

  • 00851607003297 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-001-TAB
In Commercial Distribution

  • 00851607003280 ()
  • 10851607003287 ()


  • Manometric gastrointestinal motility analysis system
Medspira Anorectal Manometry and Biofeedback System
MEDSPIRA, LLC
RMD-003
In Commercial Distribution

  • 00851607003273 ()
  • 10851607003270 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-007
In Commercial Distribution

  • 00851607003266 ()
  • 10851607003263 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-006
In Commercial Distribution

  • 00851607003259 ()
  • 10851607003256 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-002-MON
In Commercial Distribution

  • 00851607003235 ()
  • 10851607003232 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-002-VGA
In Commercial Distribution

  • 00851607003174 ()
  • 10851607003171 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-010-001
In Commercial Distribution

  • 00851607003143 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-002-POUCH
In Commercial Distribution

  • 00851607003099 ()
  • 10851607003096 ()


  • Manometric gastrointestinal motility analysis system
Medspira Biofeedback Anorectal Manometry System
MEDSPIRA, LLC
RMD-002
In Commercial Distribution

  • 10851607003065 ()
  • 00851607003068 ()
RMD-002

  • Manometric gastrointestinal motility analysis system
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