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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 - 00846468043025

CANNULATED SCREW, FIXED
Pioneer Surgical Technology, Inc.
51-575-FX-30
Not in Commercial Distribution

  • 00846468043025 ()
51-575-FX-30

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468043001

ROD, STRAIGHT
Pioneer Surgical Technology, Inc.
51-55-RR-65
Not in Commercial Distribution

  • 00846468043001 ()
51-55-RR-65

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042998

ROD, STRAIGHT
Pioneer Surgical Technology, Inc.
51-55-RR-60
Not in Commercial Distribution

  • 00846468042998 ()
51-55-RR-60

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042981

ROD, STRAIGHT
Pioneer Surgical Technology, Inc.
51-55-RR-55
Not in Commercial Distribution

  • 00846468042981 ()
51-55-RR-55

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042974

ROD, STRAIGHT
Pioneer Surgical Technology, Inc.
51-55-RR-50
Not in Commercial Distribution

  • 00846468042974 ()
51-55-RR-50

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042967

ROD, STRAIGHT
Pioneer Surgical Technology, Inc.
51-55-RR-45
Not in Commercial Distribution

  • 00846468042967 ()
51-55-RR-45

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042950

ROD, STRAIGHT
Pioneer Surgical Technology, Inc.
51-55-RR-40
Not in Commercial Distribution

  • 00846468042950 ()
51-55-RR-40

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042943

ROD, STRAIGHT
Pioneer Surgical Technology, Inc.
51-55-RR-35
Not in Commercial Distribution

  • 00846468042943 ()
51-55-RR-35

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042936

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-90
Not in Commercial Distribution

  • 00846468042936 ()
51-55-PR-90

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042929

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-80
Not in Commercial Distribution

  • 00846468042929 ()
51-55-PR-80

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042905

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-60
Not in Commercial Distribution

  • 00846468042905 ()
51-55-PR-60

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042899

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

  • 00846468042899 ()
51-55-PR-55

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042882

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-50
Not in Commercial Distribution

  • 00846468042882 ()
51-55-PR-50

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042875

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-45
Not in Commercial Distribution

  • 00846468042875 ()
51-55-PR-45

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042868

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-40
Not in Commercial Distribution

  • 00846468042868 ()
51-55-PR-40

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042851

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-35
Not in Commercial Distribution

  • 00846468042851 ()
51-55-PR-35

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042844

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-150
Not in Commercial Distribution

  • 00846468042844 ()
51-55-PR-150

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042837

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-140
Not in Commercial Distribution

  • 00846468042837 ()
51-55-PR-140

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042820

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-130
Not in Commercial Distribution

  • 00846468042820 ()
51-55-PR-130

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

QUANTUM™* MIS CANNULATED SYSTEM - 00846468042813

MIS ROD
Pioneer Surgical Technology, Inc.
51-55-PR-120
Not in Commercial Distribution

  • 00846468042813 ()
51-55-PR-120

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

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

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

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
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