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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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American Red Cross - B268Y77900

American Red Cross Infrared non-Contact Forehead Thermometer
TOMY INTERNATIONAL, INC.
Y7790
In Commercial Distribution

  • B268Y77904 ()
  • B268Y77901 ()
  • B268Y77900 ()
Y7790

  • General-purpose patient temperature probe, reusable

The First Years - B268Y7057A51

Health and Grooming Kit
TOMY INTERNATIONAL, INC.
Y7057A5
In Commercial Distribution

  • B268Y7057A51 ()
  • B268Y7057A53 ()
  • B268Y7057A59 ()
Y7057A5

  • Infant care kit

American Red Cross - B268Y108960

Ear Thermometer
TOMY INTERNATIONAL, INC.
Y10896
In Commercial Distribution

  • B268Y108964 ()
  • B268Y108961 ()
  • B268Y108960 ()
Y10896

  • General-purpose patient temperature probe, reusable

ScanX Swift Digital Imaging System - D678G80100

A device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose. This kit contains an installation disc, USB cable and power supply, PSPs, barrier envelopes, barrier film rolls, PSP wipes, and a scanner cleaning sheet.
AIR TECHNIQUES, INC.
G8010
In Commercial Distribution

  • D678G80001 ()
  • D678G80100 ()
  • D678G80101 ()

  • Weight: 14.5 Pound
  • Outer Diameter: 9.6 Inch
  • Height: 9.2 Inch
  • Width: 8.9 Inch


  • Radiography digital imaging scanner

ScanX Duo - D678D11000

The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
D1100
In Commercial Distribution

  • D678D11000 ()
  • D678D1000F1 ()
  • D678D11001 ()

  • Height: 12 Inch
  • Depth: 10.375 Inch
  • Width: 10 Inch
  • Weight: 21.5 Pound


  • Radiography digital imaging scanner

PATTERSON - D6620708881802

LEVEL 3/BLUE
PATTERSON DENTAL SUPPLY, INC.
070888180
In Commercial Distribution

  • D6620708881806 ()
  • D6620708881804 ()
  • D6620708881802 ()
  • D6620708881800 ()


  • Surgical/medical respirator, non-antimicrobial, single-use

PATTERSON - D6620708881312

LEVEL 2/LAVENDER
PATTERSON DENTAL SUPPLY, INC.
070888131
In Commercial Distribution

  • D6620708881316 ()
  • D6620708881314 ()
  • D6620708881312 ()
  • D6620708881310 ()


  • Surgical/medical respirator, non-antimicrobial, single-use

PATTERSON - D6620708881152

LEVEL 2/BLUE
PATTERSON DENTAL SUPPLY, INC.
070888115
In Commercial Distribution

  • D6620708881156 ()
  • D6620708881154 ()
  • D6620708881152 ()
  • D6620708881150 ()


  • Surgical/medical respirator, non-antimicrobial, single-use

CamX Spectra Caries Detection Aid - D678G41000

The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
AIR TECHNIQUES, INC.
G4100
In Commercial Distribution

  • D678G41000 ()
  • D678G40001 ()
  • DG78G41001 ()


  • Dental caries detector, optical induced fluorescence

ScanX 12 SE - D678F38050

ScanX 12 SE is a device that scans photostimulable phosphor plates that have been exposed in the place of x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It is used as a podiatry unit.
AIR TECHNIQUES, INC.
F3805
In Commercial Distribution

  • D678F38050 ()
  • D678F38051 ()
  • D678F38001 ()

  • Depth: 14 Inch
  • Width: 14 Inch
  • Height: 28 Inch


  • Radiography digital imaging scanner

PATTERSON - D6620708881232

LEVEL 2/PINK
PATTERSON DENTAL SUPPLY, INC.
070888123
In Commercial Distribution

  • D6620708881236 ()
  • D6620708881234 ()
  • D6620708881232 ()
  • D6620708881230 ()


  • Surgical/medical respirator, non-antimicrobial, single-use

PATTERSON - D6620708880732

LEVEL 1/PINK
PATTERSON DENTAL SUPPLY, INC.
070888073
In Commercial Distribution

  • D6620708880736 ()
  • D6620708880734 ()
  • D6620708880732 ()
  • D6620708880730 ()


  • Surgical/medical respirator, non-antimicrobial, single-use

PATTERSON - D6620708880652

LEVEL 1/BLUE
PATTERSON DENTAL SUPPLY, INC.
070888065
In Commercial Distribution

  • D6620708880656 ()
  • D6620708880654 ()
  • D6620708880652 ()
  • D6620708880650 ()


  • Surgical/medical respirator, non-antimicrobial, single-use

ISEN-Goggles - B499V060

The !SEN-Goggles are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements. This device consists of patient eye goggles ("ISEN-Goggles"). They have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USS port to facilitate transfer of data captured and stored in the device's SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for near-simultaneous viewing of the video images from both eyes on the attached LCD screen.
ISEN Tech. & Trading Co.,Ltd.
V06
In Commercial Distribution

  • B499V062 ()
  • B499V061 ()
  • B499V060 ()


  • Nystagmus inducing optokinetic drum
  • Nystagmus inducing tape

Vitale - B492245060

Vitale Cover Dressings, 6" x 6", 30/box, 10 boxes/case
CELLERA LLC
24506
In Commercial Distribution

  • B492245062 ()
  • B492245061 ()
  • B492245060 ()
24506

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492245040

Vitale Cover Dressings, 4" x 4", 30/box, 8 boxes/case
CELLERA LLC
24504
In Commercial Distribution

  • B492245042 ()
  • B492245041 ()
  • B492245040 ()
24504

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492245020

Vitale Cover Dressings, 2" x 2", 30/box, 8 boxes/case
CELLERA LLC
24502
In Commercial Distribution

  • B492245022 ()
  • B492245021 ()
  • B492245020 ()
24502

  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Vitale - B492238440

Vitale Hydrogel Dressing, 4"x4", 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
23844
In Commercial Distribution

  • B492238440 ()
  • B492238441 ()
  • B492238442 ()
23844

  • Wound hydrogel dressing, non-antimicrobial

Vitale - B492238220

Vitale Hydrogel Impregnated Dressing, 2x2, 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
23822
In Commercial Distribution

  • B492238222 ()
  • B492238221 ()
  • B492238220 ()
23822

  • Wound hydrogel dressing, non-antimicrobial

Vitale - B492212900

Vitale Sacral Hydrocolloid Dressing, 6x7, 1/pouch, 10/box, 10 boxes/case
CELLERA LLC
21290
In Commercial Distribution

  • B492212900 ()
  • B492212901 ()
  • B492212902 ()
21290

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
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