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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
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