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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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MEDRAD® MRXperion MR Injection System - 00616258008141

"Assy, IV Pole, MRXperion (84290149)"
BAYER MEDICAL CARE INC.
MRXP IV D
In Commercial Distribution

  • 00616258008141 ()
MRXP IV D

  • MRI contrast medium injection system, line-powered, mobile

MEDRAD® MRXperion MR Injection System - 00616258008134

"SYSTEM,INJECTOR,MRXPERION (84200085)"
BAYER MEDICAL CARE INC.
MRXperion
In Commercial Distribution

  • 00616258008134 ()
MRXP 200

  • MRI contrast medium injection system, line-powered, mobile

Quantum® BacFuse® Spinous Process Fusion Plate - 00846468047801

Driver
Pioneer Surgical Technology, Inc.
83-DRIVER
Not in Commercial Distribution

  • 00846468047801 ()
83-DRIVER

  • Orthopaedic counter-torque/rod-pushing instrument

CLARITY ® RETRACTOR SYSTEM - 00846468044541

MIS ARTICULATING RETRACTOR/DRIVER
Pioneer Surgical Technology, Inc.
53-DRIVER
Not in Commercial Distribution

  • 00846468044541 ()


  • General internal orthopaedic fixation system implantation kit

N/A - 00846468041045

HEX DRIVER, 3.5mm
Pioneer Surgical Technology, Inc.
405-696
Not in Commercial Distribution

  • 00846468041045 ()
405-696

  • General internal orthopaedic fixation system implantation kit

Songer® Spinal Cable System - 00846468040932

Torque Driver
Pioneer Surgical Technology, Inc.
400-908
Not in Commercial Distribution

  • 00846468040932 ()


  • Internal spinal fixation system cable

Streamline® OCT Occipito-Cervico-Thoracic System - 00846468027490

DRIVER, SET SCREW
Pioneer Surgical Technology, Inc.
23-SETSCREWINS
Not in Commercial Distribution

  • 00846468027490 ()


  • General internal orthopaedic fixation system implantation kit

Streamline® OCT Occipito-Cervico-Thoracic System - 00846468027391

NUT DRIVER
Pioneer Surgical Technology, Inc.
23-NUTDRIVER
Not in Commercial Distribution

  • 00846468027391 ()


  • General internal orthopaedic fixation system implantation kit

STREAMLINE® CT CERVICO-THORACIC SYSTEM - 00846468027292

SET SCREW FINAL DRIVER
Pioneer Surgical Technology, Inc.
23-FINALDRIVER
Not in Commercial Distribution

  • 00846468027292 ()
23-FINALDRIVER

  • Spinal bone screw, non-bioabsorbable

SLIMFUSE™* ANTERIOR CERVICAL PLATE SYSTEM - 00846468025960

DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
21-TORQ-HANDLE
Not in Commercial Distribution

  • 00846468025960 ()


  • General internal orthopaedic fixation system implantation kit
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