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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 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® BacFuse® Spinous Process Fusion Plate - 00846468041816

BOTTOM TRAY
Pioneer Surgical Technology, Inc.
430-162
Not in Commercial Distribution

  • 00846468041816 ()
430-162

  • Device sterilization/disinfection container, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468041809

MIDDLE TRAY
Pioneer Surgical Technology, Inc.
430-161
Not in Commercial Distribution

  • 00846468041809 ()
430-161

  • Device sterilization/disinfection container, reusable

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468041793

TOP TRAY
Pioneer Surgical Technology, Inc.
430-160
Not in Commercial Distribution

  • 00846468041793 ()
430-160

  • Device sterilization/disinfection container, 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
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