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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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Quantum SuperPAC Cardioplegia Tubing Set 1/4 - CGSP8-B1 - 18051160303097

No Description
SPECTRUM MEDICAL SRL
CGSP8-B1
In Commercial Distribution

  • 18051160303097 ()


  • Cardioplegia solution administration kit

Quantum SuperPAC Cardioplegia Tubing Set 1/4 - CGSP8-B0 - 18051160302809

No Description
SPECTRUM MEDICAL SRL
CGSP8-B0
In Commercial Distribution

  • 18051160302809 ()


  • Cardioplegia solution administration kit

Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U - 18051160301857

No Description
SPECTRUM MEDICAL SRL
VT75-C2U
In Commercial Distribution

  • 18051160301857 ()


  • Extracorporeal membrane oxygenator

STARKEY - 00842318189837

No Description
Starkey Laboratories, Inc.
EVOLV AI IIC NW
In Commercial Distribution

  • 00842318189837 ()


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

STARKEY - 00842318189721

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

  • 00842318189721 ()


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

STARKEY - 00842318189714

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

  • 00842318189714 ()


  • Air-conduction hearing aid, in-the-ear
  • Tinnitus masking application software

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 - 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

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

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
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