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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™* SPINAL FIXATION SYSTEM - 00846468018771

X-LINK™, VARIABLE
Pioneer Surgical Technology, Inc.
10-3040-VXL
Not in Commercial Distribution

  • 00846468018771 ()
10-3040-VXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018764

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-28-FXL
Not in Commercial Distribution

  • 00846468018764 ()
10-28-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018757

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-26-FXL
Not in Commercial Distribution

  • 00846468018757 ()
10-26-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018740

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-24-FXL
Not in Commercial Distribution

  • 00846468018740 ()
10-24-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018733

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-22-FXL
Not in Commercial Distribution

  • 00846468018733 ()
10-22-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018726

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-20-FXL
Not in Commercial Distribution

  • 00846468018726 ()
10-20-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018719

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-18-FXL
Not in Commercial Distribution

  • 00846468018719 ()
10-18-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018702

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-17-FXL
Not in Commercial Distribution

  • 00846468018702 ()
10-17-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018696

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-16-FXL
Not in Commercial Distribution

  • 00846468018696 ()
10-16-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018689

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-15-FXL
Not in Commercial Distribution

  • 00846468018689 ()
10-15-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018672

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-14-FXL
Not in Commercial Distribution

  • 00846468018672 ()
10-14-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018665

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-13-FXL
Not in Commercial Distribution

  • 00846468018665 ()
10-13-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018658

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-12-FXL
Not in Commercial Distribution

  • 00846468018658 ()
10-12-FXL

  • Bone-screw internal spinal fixation system, non-sterile

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468018641

X-LINK™, FIXED
Pioneer Surgical Technology, Inc.
10-11-FXL
Not in Commercial Distribution

  • 00846468018641 ()
10-11-FXL

  • Bone-screw internal spinal fixation system, non-sterile

VESALIUS QUANTUM Galileo bipolar scissors - 08034055291559

No Description
TELEA ELECTRONIC ENGEENERING SRL
L=140mm with cable
In Commercial Distribution

  • 08034055291559 ()
2601018

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Quantum Perfusion Capnometer Line Set - 08051160302130

No Description
SPECTRUM MEDICAL SRL
CAP-SP1
In Commercial Distribution

  • 08051160302130 ()


  • Gas-sampling/monitoring respiratory tubing, single-use

Quantum SuperPAC Tubing Set - SP03E-AA - 08051160301706

No Description
SPECTRUM MEDICAL SRL
SP03E-AA
Not in Commercial Distribution

  • 08051160301706 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02E-AA - 08051160301690

No Description
SPECTRUM MEDICAL SRL
SP02E-AA
Not in Commercial Distribution

  • 08051160301690 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP01V-AA - 08051160301522

No Description
SPECTRUM MEDICAL SRL
SP01V-AA
Not in Commercial Distribution

  • 08051160301522 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP01C-DA - 08051160301492

No Description
SPECTRUM MEDICAL SRL
SP01C-DA
Not in Commercial Distribution

  • 08051160301492 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP01E-AA - 08051160301461

No Description
SPECTRUM MEDICAL SRL
SP01E-AA
Not in Commercial Distribution

  • 08051160301461 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum Perfusion Arterial Cannula Graft - 08051160300839

No Description
SPECTRUM MEDICAL SRL
AG08-V0
In Commercial Distribution

  • 08051160300839 ()


  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

Quantum Perfusion Blood Oxygenator VT160-E2 - 08051160300747

No Description
SPECTRUM MEDICAL SRL
VT160-E2
In Commercial Distribution

  • 08051160300747 ()


  • Extracorporeal membrane oxygenator

Quantum Perfusion Blood Oxygenator VT160-E1 - 08051160300730

No Description
SPECTRUM MEDICAL SRL
VT160-E1
In Commercial Distribution

  • 08051160300730 ()


  • Extracorporeal membrane oxygenator

Quantum Perfusion Blood Oxygenator VT200-E2 - 08051160300686

No Description
SPECTRUM MEDICAL SRL
VT200-E2
In Commercial Distribution

  • 08051160300686 ()


  • Extracorporeal membrane oxygenator

Quantum Perfusion Blood Oxygenator VT200-E1 - 08051160300679

No Description
SPECTRUM MEDICAL SRL
VT200-E1
In Commercial Distribution

  • 08051160300679 ()


  • Extracorporeal membrane oxygenator

VESALIUS QUANTUM Galileo bipolar scissors - 08034055296028

No Description
TELEA ELECTRONIC ENGEENERING SRL
L=175mm with cable
In Commercial Distribution

  • 08034055296028 ()
2601027

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Quantum SuperPAC Tubing set - SP09C-AA - 18051160302854

No Description
SPECTRUM MEDICAL SRL
SP09C-AA
In Commercial Distribution

  • 18051160302854 ()


  • Cardioplegia solution administration kit

Quantum SuperPAC Tubing set - SP07C-AA - 18051160302816

No Description
SPECTRUM MEDICAL SRL
SP07C-AA
Not in Commercial Distribution

  • 18051160302816 ()


  • Cardioplegia solution administration kit

Quantum SuperPAC Tubing Set - SP02C-AB - 18051160302038

No Description
SPECTRUM MEDICAL SRL
SP02C-AB
Not in Commercial Distribution

  • 18051160302038 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02C-DA - 18051160302021

No Description
SPECTRUM MEDICAL SRL
SP02C-DA
Not in Commercial Distribution

  • 18051160302021 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing set - SP09C-DA - 18051160302847

No Description
SPECTRUM MEDICAL SRL
SP09C-DA
In Commercial Distribution

  • 18051160302847 ()


  • Cardioplegia solution administration kit

Quantum SuperPAC Tubing set - SP08C-AA - 18051160302830

No Description
SPECTRUM MEDICAL SRL
SP08C-AA
In Commercial Distribution

  • 18051160302830 ()


  • Cardioplegia solution administration kit

Quantum SuperPAC Tubing set - SP07C-DA - 18051160302755

No Description
SPECTRUM MEDICAL SRL
SP07C-DA
Not in Commercial Distribution

  • 18051160302755 ()


  • Cardioplegia solution administration kit

Quantum SuperPAC Tubing Set - SP02C-BC - 18051160302045

No Description
SPECTRUM MEDICAL SRL
SP02C-BC
Not in Commercial Distribution

  • 18051160302045 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02V-BB - 18051160302014

No Description
SPECTRUM MEDICAL SRL
SP02V-BB
Not in Commercial Distribution

  • 18051160302014 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02V-AA - 18051160302007

No Description
SPECTRUM MEDICAL SRL
SP02V-AA
Not in Commercial Distribution

  • 18051160302007 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02E-CC - 18051160301994

No Description
SPECTRUM MEDICAL SRL
SP02E-CC
Not in Commercial Distribution

  • 18051160301994 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Tubing Set - SP02E-BB - 18051160301987

No Description
SPECTRUM MEDICAL SRL
SP02E-BB
Not in Commercial Distribution

  • 18051160301987 ()


  • Cardiopulmonary bypass system blood tubing set

Quantum Perfusion Blood Oxygenator VT75-E2 - 18051160301871

No Description
SPECTRUM MEDICAL SRL
VT75-E2
In Commercial Distribution

  • 18051160301871 ()


  • Extracorporeal membrane oxygenator
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