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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 - 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

Quantum BacFuse Spinous Process Fusion Plate - 00846468091972

Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-10
Not in Commercial Distribution

83-00-10

  • Spinal fixation plate, non-bioabsorbable

Quantum BacFuse Spinous Process Fusion Plate - 00846468091965

Spinous Process Fusion Plate
Pioneer Surgical Technology, Inc.
83-00-08
Not in Commercial Distribution

83-00-08

  • Spinal fixation plate, non-bioabsorbable

KIT Quantum SuperPAC Tubing Set - 160R - 28051160302530

No Description
SPECTRUM MEDICAL SRL
SPC-160R
In Commercial Distribution

  • 28051160302530 ()


  • Cardiopulmonary bypass system blood tubing set

KIT Quantum SuperPAC Tubing Set - 200R - 28051160302509

No Description
SPECTRUM MEDICAL SRL
SPC-200R
In Commercial Distribution

  • 28051160302509 ()


  • Cardiopulmonary bypass system blood tubing set

KIT Quantum SuperPAC Tubing Set - 160 - 28051160302479

No Description
SPECTRUM MEDICAL SRL
SPC-160
Not in Commercial Distribution

  • 28051160302479 ()


  • Cardiopulmonary bypass system blood tubing set

KIT Quantum SuperPAC Tubing Set - 200 - 28051160302462

No Description
SPECTRUM MEDICAL SRL
SPC-200
Not in Commercial Distribution

  • 28051160302462 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum Perfusion Centrifugal Blood Pump CP20 - 18051160302144

No Description
SPECTRUM MEDICAL SRL
CP20V-V0U
In Commercial Distribution

  • 18051160302144 ()


  • Cardiopulmonary bypass system centrifugal pump

Quantum Perfusion SuperPAC Tubing set - SP05E-AA - 18051160302717

No Description
SPECTRUM MEDICAL SRL
SP05E-AA
In Commercial Distribution

  • 18051160302717 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum Perfusion Dual Lumen Cannula 31F-V1 - 18051160302694

No Description
SPECTRUM MEDICAL SRL
DL31F-V1
In Commercial Distribution

  • 18051160302694 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

STARKEY - 00842318189738

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

  • 00842318189738 ()


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