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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
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