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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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STARKEY - 00842318189707

No Description
Starkey Laboratories, Inc.
EVOLV AI ITC R
In Commercial Distribution

  • 00842318189707 ()


  • Tinnitus masking application software
  • Air-conduction hearing aid, canal

InModeRF hand piece - 07290019863069

Fractional RF Quantum Handpiece which comprises canula with active electrodes, handle, cable and connector Handpiece HP1022B6A has a canula diameter of 2mm and 10cm long. Maximal RF power is 35W.
INMODE M.D LTD
HP1022B6A
In Commercial Distribution

  • 07290019863069 ()
HP1022B6A

  • Radio-frequency fat liquefaction system

InModeRF hand piece - 07290019863076

Fractional RF Quantum Handpiece which comprises canula with active electrodes, handle, cable and connector Handpiece HP2539B6A has a canula of 3.3mm diameter and 25cm long. Maximal RF power is 60W.
INMODE M.D LTD
HP2539B6A
In Commercial Distribution

  • 07290019863076 ()
HP2539B6A

  • Radio-frequency fat liquefaction system

Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 1/4 - 08051160301232

No Description
SPECTRUM MEDICAL SRL
HX22W-C1
In Commercial Distribution

  • 08051160301232 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 - 08051160301225

No Description
SPECTRUM MEDICAL SRL
HX22W-C0
In Commercial Distribution

  • 08051160301225 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 - 08051160301218

No Description
SPECTRUM MEDICAL SRL
HX32W-C0
In Commercial Distribution

  • 08051160301218 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 - 08051160301201

No Description
SPECTRUM MEDICAL SRL
HX11W-S1
In Commercial Distribution

  • 08051160301201 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 - 08051160301195

No Description
SPECTRUM MEDICAL SRL
HX11W-S0
In Commercial Distribution

  • 08051160301195 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 - 08051160301188

No Description
SPECTRUM MEDICAL SRL
HX22W-S0
In Commercial Distribution

  • 08051160301188 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Standard Heat Exchanger High Flow 3/8 - 08051160301171

No Description
SPECTRUM MEDICAL SRL
HX55W-S0
In Commercial Distribution

  • 08051160301171 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Standard Heat Exchanger Medium Flow 3/8 - 08051160301003

No Description
SPECTRUM MEDICAL SRL
HX22W-S1
In Commercial Distribution

  • 08051160301003 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors - 08051160300846

No Description
SPECTRUM MEDICAL SRL
CP20V-VT
In Commercial Distribution

  • 08051160300846 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors - 08051160300624

No Description
SPECTRUM MEDICAL SRL
CP22V-VT
In Commercial Distribution

  • 08051160300624 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors - 18051160302991

No Description
SPECTRUM MEDICAL SRL
CP22V-NG
In Commercial Distribution

  • 18051160302991 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors - 18051160302663

No Description
SPECTRUM MEDICAL SRL
CP37V-VT
In Commercial Distribution

  • 18051160302663 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum PureFlow Standard Heat Exchanger Low Flow 3/8 - 18051160302151

No Description
SPECTRUM MEDICAL SRL
HX11W-S2
In Commercial Distribution

  • 18051160302151 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U - 08051160301447

No Description
SPECTRUM MEDICAL SRL
VT160-C1U
In Commercial Distribution

  • 08051160301447 ()


  • Extracorporeal membrane oxygenator

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U - 08051160301423

No Description
SPECTRUM MEDICAL SRL
VT200-C1U
In Commercial Distribution

  • 08051160301423 ()


  • Extracorporeal membrane oxygenator

Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 1/4 - PL - 08051160301263

No Description
SPECTRUM MEDICAL SRL
HX22W-C5
In Commercial Distribution

  • 08051160301263 ()


  • Cardiopulmonary bypass system heat exchanger, single-use

Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 - PL - 08051160301256

No Description
SPECTRUM MEDICAL SRL
HX22W-C4
In Commercial Distribution

  • 08051160301256 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
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