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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 - 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
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