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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® BacFuse® Spinous Process Fusion Plate - 00846468047863

14mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-14
Not in Commercial Distribution

  • 00846468047863 ()
83-RASP-14

  • Bone file/rasp, manual, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047856

12mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-12
Not in Commercial Distribution

  • 00846468047856 ()
83-RASP-12

  • Bone file/rasp, manual, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047849

10mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-10
Not in Commercial Distribution

  • 00846468047849 ()
83-RASP-10

  • Bone file/rasp, manual, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047832

8mm Rasp
Pioneer Surgical Technology, Inc.
83-RASP-08
Not in Commercial Distribution

  • 00846468047832 ()
83-RASP-08

  • Bone file/rasp, manual, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047825

Lock Plate Inserter
Pioneer Surgical Technology, Inc.
83-L-INSERTER
Not in Commercial Distribution

  • 00846468047825 ()
83-L-INSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047818

Compressor
Pioneer Surgical Technology, Inc.
83-L-COMPRESSOR
Not in Commercial Distribution

  • 00846468047818 ()
83-L-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047801

Driver
Pioneer Surgical Technology, Inc.
83-DRIVER
Not in Commercial Distribution

  • 00846468047801 ()
83-DRIVER

  • Orthopaedic counter-torque/rod-pushing instrument

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047795

8mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-08
Not in Commercial Distribution

  • 00846468047795 ()
83-DILATOR-08

  • Nerve/vessel retractor

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047788

5mm Dilator
Pioneer Surgical Technology, Inc.
83-DILATOR-05
Not in Commercial Distribution

  • 00846468047788 ()
83-DILATOR-05

  • Nerve/vessel retractor

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047757

Barrel Plate Inserter
Pioneer Surgical Technology, Inc.
83-B-INSERTER
Not in Commercial Distribution

  • 00846468047757 ()
83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U - 08051160301454

No Description
SPECTRUM MEDICAL SRL
VT160-C2U
In Commercial Distribution

  • 08051160301454 ()


  • Extracorporeal membrane oxygenator

Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U - 08051160301430

No Description
SPECTRUM MEDICAL SRL
VT200-C2U
In Commercial Distribution

  • 08051160301430 ()


  • Extracorporeal membrane oxygenator

Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2 - 08051160300761

No Description
SPECTRUM MEDICAL SRL
VT160-C2
In Commercial Distribution

  • 08051160300761 ()


  • Extracorporeal membrane oxygenator

Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2 - 08051160300709

No Description
SPECTRUM MEDICAL SRL
VT200-C2
In Commercial Distribution

  • 08051160300709 ()


  • Extracorporeal membrane oxygenator

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 - 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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