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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 - 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 - 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 - 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 - 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 - 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 - 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 - 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

Sunquest Application Interfacing - B236AI5300

Sunquest Application Interface (AI) is to provide interfaces between client systems and Sunquest products to support laboratories in the management of laboratory workflow (order entry through reporting) and transfer test results and information
CliniSys, Inc
5.3
Not in Commercial Distribution

  • B236AI5300 ()


  • Clinical laboratory information system application software

Quantum PureFlow KIT CPC - Hansen Connector Adaptor - 08051160301577

No Description
SPECTRUM MEDICAL SRL
CONN-HX2
In Commercial Distribution

  • 08051160301577 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
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