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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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COE® - D6582502111

COE® SPACER TRAYS #21D Medium Lower Perforated
Gc America Inc.
250211
In Commercial Distribution

  • D6582502162 ()
  • D6582502111 ()
  • D6582521124 ()
  • D6582502110 ()
250211

  • Dental impression tray, single-use

COE® - D6582502011

COE® SPACER TRAYS #20D Large Lower Perforated
Gc America Inc.
250201
In Commercial Distribution

  • D6582520124 ()
  • D6582502062 ()
  • D6582502011 ()
  • D6582502010 ()
250201

  • Dental impression tray, single-use

COE® - D6582500961

COE® SPACER TRAYS Perforated Assorted Package
Gc America Inc.
250096
In Commercial Distribution

  • D6582500962 ()
  • D6582500961 ()
  • D6582501124 ()
  • D6582500960 ()
250096

  • Dental impression tray, single-use

COE® - D6582500711

COE® SPACER TRAYS #7D Small Upper Perforated
Gc America Inc.
250071
In Commercial Distribution

  • D6582500762 ()
  • D6582500711 ()
  • D6582507124 ()
  • D6582500710 ()
250071

  • Dental impression tray, single-use

COE® - D6582500411

COE® SPACER TRAYS #4D Medium Upper Perforated
Gc America Inc.
250041
In Commercial Distribution

  • D6582500462 ()
  • D6582500411 ()
  • D6582504124 ()
  • D6582500410 ()
250041

  • Dental impression tray, single-use

COE® - D6582500111

COE® SPACER TRAYS #1D Large Upper Perforated
Gc America Inc.
250011
In Commercial Distribution

  • D6582500124 ()
  • D6582500162 ()
  • D6582500111 ()
  • D6582500110 ()
250011

  • Dental impression tray, single-use

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

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

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 - D6620708881232

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

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


  • 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

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

reVive Light Therapy® - B347RVGLOAC0

No Description
LED TECHNOLOGIES INC
RVGLOAC
In Commercial Distribution

  • B347RVGLOAC1 ()
  • B347RVGLOAC0 ()
  • B347RVGLOAC2 ()


  • Blue/red/infrared phototherapy lamp

Glo Skin Beauty - B34757560

No Description
LED TECHNOLOGIES INC
5756
In Commercial Distribution

  • B34757561 ()
  • B34757560 ()
  • B34757562 ()


  • Blue/red/infrared phototherapy lamp

Nasal Alar Sp02 Sensor - B213301112140

The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. The Assurance® Nasal Alar SpO2™ Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
XHALE ASSURANCE, INC.
301-11214
In Commercial Distribution

  • B213301112140 ()
  • B213301112141 ()
  • B213301112142 ()


  • Pulse oximeter probe, single-use

Nasal Alar Sp02 Sensor - B21303030

The Assurance® Nasal Alar SpO2™ Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (weighing > 30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision. The Assurance® Nasal Alar SpO2™ Sensor is for use with compatible pulse oximeters. These include: Nellcor OxiMax and Oxisensor II compatible monitors and Philips FAST compatible monitors.
XHALE ASSURANCE, INC.
0303
In Commercial Distribution

  • B21303031 ()
  • B21303030 ()
  • B21303032 ()


  • Pulse oximeter probe, single-use
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