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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™* MIS CANNULATED SYSTEM - 00846468042806

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-110
Not in Commercial Distribution

  • 00846468042806 ()
51-55-PR-110

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042790

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-100
Not in Commercial Distribution

  • 00846468042790 ()
51-55-PR-100

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

QUANTUM™* SPINAL FIXATION SYSTEM - 00846468050559

ROD, HEX END
Pioneer Surgical Technology, Inc.
10-55-RH-600
Not in Commercial Distribution

  • 00846468050559 ()
10-55-RH-600

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

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 ® System M ® - 05060434420640

Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS4-130
In Commercial Distribution

  • 05060434420640 ()
51-000041-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420633

Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 2m
SPECTRUM MEDICAL LIMITED
HBS1-200
In Commercial Distribution

  • 05060434420633 ()
51-000040-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420626

Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 2m
SPECTRUM MEDICAL LIMITED
HBS2-200
In Commercial Distribution

  • 05060434420626 ()
51-000039-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420602

Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 2m
SPECTRUM MEDICAL LIMITED
HBS4-200
In Commercial Distribution

  • 05060434420602 ()
51-000037-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420138

Tube ID 1/2" x Wall 3/32" (OD 11/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420138 ()
H11XLD

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420121

Tube ID 3/8" x Wall 3/32" (OD 9/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420121 ()
H9XLM

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420114

Tube ID 1/4" x Wall 3/32" (OD 7/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420114 ()
H7XLH

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420107

Tube ID 1/4" x Wall 1/16" (OD 3/8")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420107 ()
H6XLE

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420091

Tube ID 3/16" x Wall 1/16" (OD 5/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420091 ()
H5XLA

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420671

Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS1-130
In Commercial Distribution

  • 05060434420671 ()
51-000044-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420664

Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 1.3m
SPECTRUM MEDICAL LIMITED
HBS2-130
In Commercial Distribution

  • 05060434420664 ()
51-000043-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420657

Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS3-130
In Commercial Distribution

  • 05060434420657 ()
51-000042-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420619

Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 2m
SPECTRUM MEDICAL LIMITED
HBS3-200
In Commercial Distribution

  • 05060434420619 ()
51-000038-00

  • Extracorporeal blood gas/pH monitor

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
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