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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 - 00846468022297

DRIVER, X-LINK®
Pioneer Surgical Technology, Inc.
10-XLINKDRIVER
Not in Commercial Distribution

  • 00846468022297 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022280

CASE, X-LINK™
Pioneer Surgical Technology, Inc.
10-XLCASE
Not in Commercial Distribution

  • 00846468022280 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022259

GAGE, X-LINK®, VARIABLE, 60mm-80mm
Pioneer Surgical Technology, Inc.
10-VXLG-6080
Not in Commercial Distribution

  • 00846468022259 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022242

GAGE, X-LINK®, VARIABLE, 40mm-60mm
Pioneer Surgical Technology, Inc.
10-VXLG-4060
Not in Commercial Distribution

  • 00846468022242 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022228

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

  • 00846468022228 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021955

STABILIZING TUBE
Pioneer Surgical Technology, Inc.
10-STABTUBE
Not in Commercial Distribution

  • 00846468021955 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021900

PEDICLE FINDER, STRAIGHT, SMALL, SQUARE TIP
Pioneer Surgical Technology, Inc.
10-SFINDER-SM-S
Not in Commercial Distribution

  • 00846468021900 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468074852

INSTRUMENT CASE
Pioneer Surgical Technology, Inc.
10-LS-QSRS-CN
Not in Commercial Distribution

  • 00846468074852 ()


  • General internal orthopaedic fixation system implantation kit

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
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