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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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Lingraphica - 00850042278109

Speech Generating Device - Dell Venue Windows - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278109 ()


  • Voice synthesizer/digitizer

Dynamyx Digital Pathology Software - 00860007120206

Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software. The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica’s Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips’ Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips’ Ultra Fast Scanner and Philips PP27QHD monitor.
OMNYX, LLC
2.4
In Commercial Distribution

  • 00860007120206 ()


  • Pathology information system application software

Santastic Infrared Forehead Thermometer - 00860004330691

No Description
BUY SUPPLY INC
PG-IRT1602
In Commercial Distribution

  • 00860004330691 ()


  • Infrared patient thermometer, ear

DCTAPER - D690BUYBACK2

Competitor Inventory Buy Back Product
Ss White Burs, Inc.
NONE
In Commercial Distribution

  • D690BUYBACK2 ()
BUYBACK

  • Carbide dental bur, single-use

CARDINAL HEALTH - 10888439901641

KIT, TOTAL KNEE
Cardinal Health 200, LLC
PO23TKBUY
In Commercial Distribution

  • 50888439901649 ()
  • 10888439901641 ()
PO23TKBUY

  • Orthopaedic surgical procedure kit, medicated

Laptop - D800WRAB5161

Laptop Instructor DELL 7710 (Trade Show)
ZIRKONZAHN SRL
WRAB5161
In Commercial Distribution

  • D800WRAB5161 ()


  • Dental milling system, CAD/CAM, laboratory

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

Panda In-Bed Scale - 00840682143721

ASSY-LAU, PANDA IN-BED SCALE, Finished good - Buy
Datex-Ohmeda, Inc.
PS1
In Commercial Distribution

  • 00840682143721 ()


  • Infant scale, electronic

Giraffe EU In-Bed Scale - 00840682143714

ASSY-LAU, GIRAFFE IN-BED SCALE EU, Finished good - Buy
DATEX-OHMEDA INC
GS EU1
Not in Commercial Distribution

  • 00840682143714 ()


  • Infant scale, electronic

Giraffe In-Bed Scale - 00840682143677

ASSY-LAU, GIRAFFE IN-BED SCALE, Finished good - Buy
Datex-Ohmeda, Inc.
GS1
In Commercial Distribution

  • 00840682143677 ()


  • Infant scale, electronic

Panda EU In-Bed Scale - 00840682143660

ASSY-LAU, PANDA IN-BED SCALE EU, Finished good - Buy
DATEX-OHMEDA INC
PS EU1
Not in Commercial Distribution

  • 00840682143660 ()


  • Infant scale, electronic

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 - 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

PLANNING STATION-ROSA ONE- USA - 03760244035127

planning station DELL 3560 QUERTY power plug B for Rosa One 3.1.5
MEDTECH
164050
In Commercial Distribution

  • 03760244035127 ()
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

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

Millennium - 00190776200282

DELL ASTIGMATISM MARKER GILLS and
Avalign Technologies, Inc.
92-CM01302
In Commercial Distribution

  • 00190776200282 ()


  • Corneal marker, reusable
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