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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 Single Lumen Cannula 22F - 08051160300822

No Description
SPECTRUM MEDICAL SRL
SL22F-V0
In Commercial Distribution

  • 08051160300822 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

Quantum Perfusion Dual Lumen Cannula 24F - 08051160300815

No Description
SPECTRUM MEDICAL SRL
DL24F-V0
In Commercial Distribution

  • 08051160300815 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

Quantum Perfusion Dual Lumen Cannula 27 - 08051160300808

No Description
SPECTRUM MEDICAL SRL
DL27F-V0
In Commercial Distribution

  • 08051160300808 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

Quantum Perfusion Dual Lumen Cannula 31F - 08051160300792

No Description
SPECTRUM MEDICAL SRL
DL31F-V0
In Commercial Distribution

  • 08051160300792 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

Quantum PureFlow Centrifugal Blood Pump CP37 - 08051160300617

No Description
SPECTRUM MEDICAL SRL
CP37V-V0
In Commercial Distribution

  • 28051160300611 ()
  • 08051160300617 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum PureFlow Centrifugal Blood Pump CP22 - 08051160300600

No Description
SPECTRUM MEDICAL SRL
CP22V-V0
In Commercial Distribution

  • 28051160300604 ()
  • 08051160300600 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum BacFuse Spinous Process Fusion Plate - 00846468002749

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

83-L-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002732

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

83-DRIVER

  • Orthopaedic counter-torque/rod-pushing instrument

Quantum BacFuse Spinous Process Fusion Plate - 00846468002725

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

83-DILATOR-08

  • Nerve/vessel retractor

Quantum BacFuse Spinous Process Fusion Plate - 00846468002718

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

83-DILATOR-05

  • Nerve/vessel retractor

Quantum BacFuse Spinous Process Fusion Plate - 00846468002701

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

  • 00846468002701 ()
83-COMPRESSOR

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002695

Instrument Case
Pioneer Surgical Technology, Inc.
83-CASE
Not in Commercial Distribution

  • 00846468002695 ()
83-CASE

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002688

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

83-B-INSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468000516

BACFUSE,INLINE TORQUE LIMITING HANDLE,UL
Pioneer Surgical Technology, Inc.
725-016
Not in Commercial Distribution

  • 00846468000516 ()

  • 30in-lbs (Torque)
725-016

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002886

Torque Limiting Handle
Pioneer Surgical Technology, Inc.
83-TORQHANDLE
Not in Commercial Distribution

83-TORQHANDLE

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002879

90° Sizing Distractor
Pioneer Surgical Technology, Inc.
83-THINSIZER-90
Not in Commercial Distribution

83-THINSIZER-90

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002862

Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-16
Not in Commercial Distribution

83-SLEEVE-16

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002855

Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-14
Not in Commercial Distribution

83-SLEEVE-14

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002848

Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-12
Not in Commercial Distribution

83-SLEEVE-12

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002831

Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-10
Not in Commercial Distribution

83-SLEEVE-10

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002824

Guide Sleeve
Pioneer Surgical Technology, Inc.
83-SLEEVE-08
Not in Commercial Distribution

83-SLEEVE-08

  • Orthopaedic implantation sleeve, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002800

Rasp
Pioneer Surgical Technology, Inc.
83-RASP-16
Not in Commercial Distribution

83-RASP-16

  • Bone file/rasp, manual, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002794

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

83-RASP-14

  • Bone file/rasp, manual, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002787

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

83-RASP-12

  • Bone file/rasp, manual, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002770

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

83-RASP-10

  • Bone file/rasp, manual, reusable

Quantum BacFuse Spinous Process Fusion Plate - 00846468002763

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

83-RASP-08

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468002756

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

83-L-INSERTER

  • General internal orthopaedic fixation system implantation kit

Quantum BacFuse Spinous Process Fusion Plate - 00846468092009

Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-16
Not in Commercial Distribution

83-00-16

  • Spinal fixation plate, non-bioabsorbable

Quantum BacFuse Spinous Process Fusion Plate - 00846468091996

Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-14
Not in Commercial Distribution

83-00-14

  • Spinal fixation plate, non-bioabsorbable

Quantum BacFuse Spinous Process Fusion Plate - 00846468091989

Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-12
Not in Commercial Distribution

83-00-12

  • Spinal fixation plate, non-bioabsorbable
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