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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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LeadConfirm - 07290114060448

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega LeadConfirm A Cable
In Commercial Distribution

  • 17290114060445 ()
  • 07290114060448 ()
STR-000061-00

  • Electrical-only medical device connection cable, single-use

LeadConfirm - 07290114060424

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega LeadConfirm B Cable
In Commercial Distribution

  • 17290114060421 ()
  • 07290114060424 ()
STR-000055-00

  • Electrical-only medical device connection cable, single-use

LeadConfirm - 07290114060417

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega LeadConfirm M Cable
In Commercial Distribution

  • 07290114060417 ()
  • 17290114060414 ()
STR-000041-00

  • Electrical-only medical device connection cable, single-use

Cannula - 07290114060400

Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet
ALPHA OMEGA ENGINEERING CO. LTD.
Standard
Not in Commercial Distribution

  • 17290114060407 ()
  • 07290114060400 ()
STR-021621-00

  • Intracerebral cannula, implantable

BIO delivery unit (Heine OMEGA) - 04987669100110

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

Bio delivery unit (OMEGA 500) - 04987669101162

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

BIO delivery unit (Heine OMEGA) - 04987669100288

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

HEINE OMEGA®500 LED - 04053755181742

No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755181742 ()
C-008.33.561

  • Indirect binocular ophthalmoscope

HEINE OMEGA®500 LED - 04053755153688

No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755153688 ()
C-008.33.502

  • Indirect binocular ophthalmoscope

LIO 577nm w/HEINE OMEGA 500 - 00813125014650

No Description
IRIDEX CORPORATION
65900-H500
In Commercial Distribution

  • 00813125014650 ()


  • General/multiple surgical diode laser system
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