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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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PLANNING STATION-ROSA ONE- USA - 03760244034922

planning station DELL 3560 Querty power plug B for Rosa One 3.1.6
MEDTECH
164050
In Commercial Distribution

  • 03760244034922 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

PLANNING STATION Rosa One -USA - 03760244034403

planning station DELL 7520 Querty power plug B for Rosa One 3.1.5 (Brain application)
MEDTECH
164017
In Commercial Distribution

  • 03760244034403 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

PLANNING STATION Rosa One - 03760244033840

planning station DELL 7520 Querty power plug B for Rosa One 3.1.4.0
MEDTECH
164017
In Commercial Distribution

  • 03760244033840 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

PLANNING STATION Rosa One - 03760244032652

planning station DELL 7520 Querty power plug B for Rosa One 3.1.1.0
MEDTECH
164017-00
Not in Commercial Distribution

  • 03760244032652 ()
ROSAS00503

  • Multi-purpose stereotactic surgery system

ROSA PLANNING STATION - 03760244030375

ROSA PLANNING STATION Laptop computer with the following minimal configuration : Windows 7, intel Pentium processor, 15,6'' screen, DVD +/- RW, USB ports, 25GB graphics card, eternet connection for PACS interface with graphical user interface for surgical planning, pre-operative navigation and frameless streotaxy.
MEDTECH
DELL 7520
Not in Commercial Distribution

  • 03760244030375 ()
ROSAS00369

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system

LRI/Toric Markers - 08175700109505

LRI Marker, 6mm & 8mm Chord Lengths, With Degree Gauge (Uses Dell/Gills Nomograms)
AURORA SURGICAL, LLC
AS3-500
In Commercial Distribution

  • 08175700109505 ()
AS3-500

  • Ophthalmic angular gauge, reusable

Ambler Surgical - 00190660104245

Dell LRI astigmatism marker (Nichamin Nomogram), 4 3/4'', 40/60/80 degree markings, rotating ring with degree markings, round handle, titanium
AMBLER SURGICAL CORP.
Dell LRI astigmatism marker (Nichamin Nomogram)
In Commercial Distribution

  • 00190660104245 ()
8302T

  • Scleral marker, reusable

Ambler Surgical - 00190660104238

Dell LRI astigmatism marker (Gills Nomogram), 4 3/4'', marks chord length of 6.0mm and 8.0mm, rotating ring with degree markings, round handle, titanium
AMBLER SURGICAL CORP.
Dell LRI astigmatism marker (Gills Nomogram)
In Commercial Distribution

  • 00190660104238 ()
8301T

  • Scleral marker, reusable

DELL FIXATION RING - 00841668128497

DELL FIXATION RING
KATENA PRODUCTS, INC.
AE-2186
In Commercial Distribution

  • 00841668128497 ()
AE-2186

  • Eyeball fixation instrument, reusable

NA - 00841983104183

No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6804-7460
Not in Commercial Distribution

  • 00841983104183 ()
RNS-6804-7460

  • Centralized patient monitor
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