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

  • 00850042278109 ()


  • Voice synthesizer/digitizer
DELL FIXATION RING
KATENA PRODUCTS, INC.
AE-2186
In Commercial Distribution

  • 00841668128497 ()
AE-2186

  • Eyeball fixation instrument, reusable
Dell Swivel Toric Mark. W/Rotating Bezel
KATENA PRODUCTS, INC.
08-12120
In Commercial Distribution

  • 00841668119952 ()
08-12120

  • Corneal marker, reusable
Dell Fixed Toric Mark. W/ Rotating Bezel
KATENA PRODUCTS, INC.
08-12119
In Commercial Distribution

  • 00841668119945 ()
08-12119

  • Corneal marker, reusable
Dell Astigmatism Marker, 6 & 8mm Cord
KATENA PRODUCTS, INC.
08-121085
In Commercial Distribution

  • 00841668119853 ()

  • Length: 8 Millimeter
  • Length: 6 Millimeter
08-121085

  • Corneal marker, reusable
Dell Astigmatism Marker
KATENA PRODUCTS, INC.
08-12108
In Commercial Distribution

  • 00841668119846 ()
08-12108

  • Corneal marker, reusable
Dell Astigmatism Marker, (Nichamin)
KATENA PRODUCTS, INC.
08-121115
In Commercial Distribution

  • 00841668119891 ()
08-121115

  • Corneal marker, reusable
HVT 2.0 Buy Out Unit
VAPOTHERM, INC.
HVT-BUYOUT
In Commercial Distribution

  • 00841737105831 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual
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
Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6803-7460
Not in Commercial Distribution

  • 00841983104176 ()
RNS-6803-7460

  • Centralized patient monitor
NEUROFAX ACQUISITION, Dell Precision Tower desktop
NIHON KOHDEN AMERICA, INC.
EEG-1200A-T
In Commercial Distribution

  • 00841983103971 ()
EEG-1200A-T

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

  • 00840682143721 ()


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

  • 00840682143714 ()


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

  • 00840682143677 ()


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

  • 00840682143660 ()


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

  • 00190776200282 ()


  • Corneal marker, reusable
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
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 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 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 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 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 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
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
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
AMSTRON AP-1222OEV BATTERY MUST BUY TWO
AADCO MEDICAL, INC.
OSP-AP12220EV
In Commercial Distribution

  • 00840348505283 ()
OSP-AP12220EV

  • Custom-made medical device mount
Young Standard Prophy Brush, Firm, Long Flat Black Brush, Metal Latch Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
092300
In Commercial Distribution

  • 10302730923008 ()
  • 00302730923001 ()
092300

  • Dental-professional prophylaxis brush, single-use
Young Prophy Brush, Soft, Long Flat White Nylon Brush, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
090700
In Commercial Distribution

  • 10302730907008 ()
  • 00302730907001 ()
090700

  • Dental-professional prophylaxis brush, single-use
Young Pointed Midget Prophy Brush, Firm, Short Pointed Black Brush, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
090500
In Commercial Distribution

  • 10302730905004 ()
  • 00302730905007 ()
090500

  • Dental-professional prophylaxis brush, single-use
Young Midget Prophy Brush, Firm, Short Flat Black Brush, Screw Type, Bulk Buy
YOUNG DENTAL MANUFACTURING I, LLC
090400
In Commercial Distribution

  • 10302730904007 ()
  • 00302730904000 ()
090400

  • Dental-professional prophylaxis brush, single-use
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