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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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AESCULAP - 04038653361458

ORTHOPILOT PASSIVE TRANSMITTER (RED)
Aesculap AG
FS635
In Commercial Distribution

  • 04038653361458 ()
FS635

  • Robotic surgical navigation system

ORTHOPILOT - 04038653350773

ORTHOPILOT STRAIGHT POINTER
Aesculap AG
FS604
In Commercial Distribution

  • 04038653350773 ()
FS604

  • Robotic surgical navigation system

ORTHOPILOT THA - 04038653349326

ORTHOPILOT THA ACTIVE POINTER 45°ANGLED
Aesculap AG
FS934
In Commercial Distribution

  • 04038653349326 ()
FS934

  • Robotic surgical navigation system

AESCULAP - 04038653254224

ORTHOPILOT ACTIVE TRANSMITTER (IR)
Aesculap AG
FS601
In Commercial Distribution

  • 04038653254224 ()
FS601

  • Robotic surgical navigation system

AESCULAP - 04038653253753

ORTHOPILOT FOOT SWITCH 2 PEDALS
Aesculap AG
FS003
In Commercial Distribution

  • 04038653253753 ()
FS003

  • Robotic surgical navigation system

ORTHOPILOT THA - 04038653422753

ORTHOPILOT THA PASSIVE RIGID BODY
Aesculap AG
FS608
In Commercial Distribution

  • 04038653422753 ()
FS608

  • Robotic surgical navigation system

AESCULAP - 04038653407019

ORTHOPILOT ACL POINTER STR
Aesculap AG
FS871M
In Commercial Distribution

  • 04038653407019 ()
FS871M

  • Robotic surgical navigation system

EPIONE - 03760305400086

The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures
QUANTUM SURGICAL
30-0001
In Commercial Distribution

  • 03760305400086 ()
30-0001-01-USA

  • Robotic surgical navigation system

Short Navigation Probe - 03760305400079

The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0044
In Commercial Distribution

  • 03760305400079 ()
02-0044

  • Robotic surgical navigation system

Needle Guide - 03760305400062

The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications.
QUANTUM SURGICAL
02-0027
In Commercial Distribution

  • 03760305400062 ()
02-0027-19G

  • Robotic surgical navigation system
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