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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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Patient Reference - 03760305400024

The Patient Reference is an instrument of the EPIONE device used to track the patient position and motions including breathing.
QUANTUM SURGICAL
02-0026
In Commercial Distribution

  • 03760305400024 ()
02-0026

  • Robotic surgical navigation system

ACUMED - 10806378039850

AI Acutrak® Comp Screw Handle Assy
Acumed LLC
80-0097
In Commercial Distribution

  • 10806378039850 ()


  • Surgical instrument handle, non-torque-limiting

Millennium - 00190776209667

Visual Obturator with AI sheath scope lock
Avalign Technologies, Inc.
72-3130073
In Commercial Distribution

  • 00190776209667 ()


  • ENT examination/treatment system

Millennium - 00190776191177

FIBER LIGHT CABLE w AI INSTRUMENT CONNECTORS
Avalign Technologies, Inc.
72-9819
In Commercial Distribution

  • 00190776191177 ()


  • Fibreoptic retractor handle

Millennium - 00190776189686

FIBER OPTIC CABLE FOR RETRACTORS AI ADAPTOR
Avalign Technologies, Inc.
MFOC-10R
In Commercial Distribution

  • 00190776189686 ()


  • Electrical-only medical device connection cable, reusable

Millennium - 00190776189570

Fiberoptic Cable A AF Blue AI Cable
Avalign Technologies, Inc.
FTIMG166288BL
In Commercial Distribution

  • 00190776189570 ()


  • Electrical-only medical device connection cable, reusable

Quantum Spinal Fixation System - 00846468002398

QUANTUM SCREW REMOVER
Pioneer Surgical Technology, Inc.
10-SCREWREMOVER
Not in Commercial Distribution

10-SCREWREMOVER

  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468060350

QUANTUM SCREW REMOVER
Pioneer Surgical Technology, Inc.
10-SCREWREMOVER
Not in Commercial Distribution

  • 00846468060350 ()


  • General internal orthopaedic fixation system implantation kit

QUANTUM - 03701337602987

QUANTUM BASE LEFT
IN2BONES
M05 10023
In Commercial Distribution

  • 03701337602987 ()
M05 10023

  • Instrument tray, reusable

QUANTUM - 03701337602970

QUANTUM BASE RIGHT
IN2BONES
M05 10022
In Commercial Distribution

  • 03701337602970 ()
M05 10022

  • Instrument tray, reusable
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