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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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Transpac™IT Monitoring Kit, 27", 30 ml Flush Device, 10 cc Contamination Syringe and Needleless Valve
ICU MEDICAL, INC.
42800-39
In Commercial Distribution

  • 10887709098166 ()
  • 00887709098169 ()
42800-39

  • Invasive blood pressure transducer set
Kinesia Web Application/Portal 2 Software
Great Lakes Neurotechnologies Inc.
360-2011, Kinesia Web App/Portal 2
In Commercial Distribution

  • 00859584006164 ()


  • Tremor transducer
OtoNova Pro system for Clinical OAE and ABR hearing test applications. Includes OtoNova Pro instrument, ear probe, system items, and Clinical licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-CLN-DTA
In Commercial Distribution

  • 05060396173172 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for DPOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DA
In Commercial Distribution

  • 05060396173158 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for TEOAE and ABR hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and TE+ABR Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-TA
In Commercial Distribution

  • 05060396173141 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
OtoNova Pro system for DPOAE and TEOAE hearing screening. Includes OtoNova Pro instrument, ear probe, system items, and DP+TE Screener licence for the Nova-link app
OTODYNAMICS LIMITED
NPRO-SCR-DT
In Commercial Distribution

  • 05060396173134 ()


  • Otoacoustic emission system, battery-powered
100% SILICONE FOLEY TRAY, NEEDLE PORT, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT
Cardinal Health 200, LLC
6070
In Commercial Distribution

  • 20884521156934 ()
  • 10884521156937 ()

  • Catheter Gauge: 14 French
  • Total Volume: 2000 Milliliter
6070

  • Indwelling urethral catheterization kit, adult
HUMI® Harris-Kronner Uterine Manipulator-Injector O.D.: 5 mm • Length: 33 cm (13") • Recommended Balloon Inflation: Air 10 cc
Coopersurgical, Inc.
6001
In Commercial Distribution

  • 20888937013232 ()
  • 00888937013238 ()


  • Uterine manipulator, single-use
EPISTAXIS BALOON CATHETER KIT. CONTAINS: ONE CATHETER, ONE 10 CC SYRINGE AND TWO 4 x 4". GAUZE PADS
Gyrus ACMI, LLC
890912
In Commercial Distribution

  • 00821925022379 ()
  • 00821925042391 ()


  • Intranasal splint, non-bioabsorbable, animal-derived
AMSure® Bulb Irrigation Syringe CONTENTS: 1 each Bulb Irrigation Syringe, 60 cc 1 each Small Tube Adapter
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411008461 ()
  • 10704411008460 ()
AS011P

  • Surgical irrigation tubing set, single-use
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