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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No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroNav Drive
In Commercial Distribution

  • 27290016450051 ()
NNW-026000-55

  • Depth electrode
NeuroNav system with NeuroFortis Drive : NeurFortis Drive requires sterilization before use.
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroFortis Drive
In Commercial Distribution

  • 27290016450044 ()
NNW-006010-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Starfix frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954100 ()
700-021508-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Libenger RM frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954094 ()
700-020874-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode
No Description
ALIMED, INC.
920177
In Commercial Distribution

  • 00733657237122 ()
2970011704

  • Operating table mattress, basic
The delivery unit is connected to the Yellow Laser Photocoagulator YLC-500 to comprise the photocoagulation system and to treat affected areas using a binocular indirect ophthalmoscope. The photocoagulation system enables photocoagulation using a yellow laser beam (577 nm) while observing the patient’s eye with the binocular indirect ophthalmoscope.
NIDEK CO.,LTD.
GDD01
In Commercial Distribution

  • 04987669101162 ()


  • General/multiple surgical frequency-doubled solid-state laser system
The Binocular Indirect Ophthalmoscope (hereafter called BIO) delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 (main body), to comprise the photocoagulation system and applied to the treatment of the affected area using the BIO delivery unit (HEINE OMEGA 500). The comprised photocoagulation system allows the operator to select between thermal photocoagulation with the multicolor laser beam (treatment beam) (wavelength: green (532 nm), yellow (577 nm), and red (647nm)) and observation with the BIO.
NIDEK CO.,LTD.
17379-0000
In Commercial Distribution

  • 04987669100110 ()


  • General/multiple surgical frequency-doubled solid-state laser system
This unit is connected to the NIDEK GREEN LASER PHOTOCOAGULATOR, Model GYC- 1000 (main body) to comprise the photocoagulation system and applied to the treatment of the affected area using the B.I.O. delivery unit (HEINE OMEGA 500). The comprised photocoagulation system makes it possible to switch between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the B.I.O.
NIDEK CO.,LTD.
17112-0000
In Commercial Distribution

  • 04987669100288 ()


  • General/multiple surgical frequency-doubled solid-state laser system
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755181742 ()
C-008.33.561

  • Indirect binocular ophthalmoscope
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