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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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CERABIEN™ MiLai - EKUR1090431KA0

3G IS Mamelon Orange 2
KURARAY NORITAKE DENTAL INC.
109-0431KA
In Commercial Distribution

  • EKUR1090431KA0 ()


  • Dental appliance fabrication material, ceramic

CERABIEN™ MiLai - EKUR1090401KA0

3G IS Incisal Blue 2
KURARAY NORITAKE DENTAL INC.
109-0401KA
In Commercial Distribution

  • EKUR1090401KA0 ()


  • Dental appliance fabrication material, ceramic

CERABIEN™ MiLai - EKUR1090391KA0

3G IS Incisal Blue 1
KURARAY NORITAKE DENTAL INC.
109-0391KA
In Commercial Distribution

  • EKUR1090391KA0 ()


  • Dental appliance fabrication material, ceramic

PROPHYflex 4 S Flamingo - EKAV300459500

This is a medical device.
KaVo Dental GmbH
3.004.5950
In Commercial Distribution

  • EKAV300459500 ()
4 S Flamingo

  • Dental abrasive air jet system handpiece

PROPHYflex 4 Lime - EKAV300282000

This is a medical device.
KaVo Dental GmbH
3.002.8200
In Commercial Distribution

  • EKAV300282000 ()
PROPHYflex 4 Lime

  • Dental abrasive air jet system handpiece

PROPHYflex 4 Wave - EKAV300280000

This is a medical device.
KaVo Dental GmbH
3.002.8000
In Commercial Distribution

  • EKAV300280000 ()
PROPHYflex 4 Wave

  • Dental abrasive air jet system handpiece

PROPHYflex perio tip - EKAV200009220

This is a medical Device.
KaVo Dental GmbH
2.000.0922
In Commercial Distribution

  • EKAV200009220 ()
perio tip

  • Dental abrasive air jet system handpiece

Packaged System, KaVo Nomad Pro2, CA - EKAV101377890

This is a medical device.
ARIBEX, INC.
1.013.7789
In Commercial Distribution

  • EKAV101377890 ()
1.013.7789

  • Diagnostic x-ray system generator, hand-held

CARETALK - 06926408700455

The device is Non-Contact thermometer, which is intended to measure human body temperature
Shenzhen Dongdixin Technology Co.,Ltd.
TH1009N
In Commercial Distribution

  • 06926408700455 ()
  • 16926408700452 ()


  • Infrared patient thermometer, skin

Little Journey - 06926408700165

The device is Non-Contact thermometer, which is intended to measure human body temperature
Shenzhen Dongdixin Technology Co.,Ltd.
KFT509
In Commercial Distribution

  • 06926408700165 ()
  • 16926408700162 ()


  • Infrared patient thermometer, skin

CARETALK - 06926408700202

The device is Non-Contact thermometer, which is intended to measure human body temperature
Shenzhen Dongdixin Technology Co.,Ltd.
TH5001N
In Commercial Distribution

  • 16926408700209 ()
  • 06926408700202 ()


  • Infrared patient thermometer, skin

N Evaporation Caps for Reagent Vials (5 ml) - 00842768012303

The N Evaporation Cap 5ml is is part of the BN ProSpec system.
Siemens Healthcare Diagnostics Products GmbH
10446535
In Commercial Distribution

  • 00842768012303 ()
  • 00842768024801 ()
OVLC31

  • Nephelometry immunoassay analyser IVD

Revi™ Clinician Programmer - 07290017912035

The Revi Clinician Programmer is an application that is the Revi system's interface.
BLUEWIND MEDICAL LTD
DV-9500-0001_US_CM
In Commercial Distribution

  • 07290017912035 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system

ID Jelly - 00761236901133

ID Jelly is a water based lubricant, and is Latex and Polyurethane Compatible.
WESTRIDGE LABORATORIES INCORPORATED
Jelly 4.4 fl oz Retail
In Commercial Distribution

  • 00761236901133 ()
  • 30761236901134 ()
IDDKRBE4

  • Sexual lubricant

ID Jelly - 00761236900808

ID Jelly is a water based lubricant, and is Latex and Polyurethane Compatible.
WESTRIDGE LABORATORIES INCORPORATED
Jelly 4 fl oz Tube
In Commercial Distribution

  • 10761236900805 ()
  • 00761236900808 ()
IDDKRT04

  • Sexual lubricant

ID Jelly - 00761236900792

ID Jelly is a water based lubricant, and is Latex and Polyurethane Compatible.
WESTRIDGE LABORATORIES INCORPORATED
Jelly 2 fl oz Travel Tube
In Commercial Distribution

  • 00761236900792 ()
  • 20761236900796 ()
IDDKRT02

  • Sexual lubricant

ID Jelly - 00761236109836

ID Jelly is a water based lubricant, and is Latex and Polyurethane Compatible.
WESTRIDGE LABORATORIES INCORPORATED
Jelly 12 ml Tube
In Commercial Distribution

  • 00761236109836 ()
  • 60761236109838 ()
  • 00761236109850 ()
  • 00761236109843 ()
IDDKRT12

  • Sexual lubricant

ID Jelly - 00761236109805

ID Jelly is a water based lubricant, and is Latex and Polyurethane Compatible.
WESTRIDGE LABORATORIES INCORPORATED
Jelly 10 ml Pillow
In Commercial Distribution

  • 00761236109805 ()
  • 40761236109803 ()
  • 00761236109829 ()
  • 00761236109812 ()
IDDKRP10

  • Sexual lubricant

Copioumed - 04719882253621

Copioumed The tie-band headwear is made of non-woven fabric, which is made by cutting and sewing. It is non-sterile and disposable.
Copious International Inc.
SCN0G191-1
In Commercial Distribution

  • 14719882253628 ()
  • 04719882253621 ()
  • 04719882253614 ()


  • Surgical cap, single-use

Copioumed - 04719882253607

Copioumed The tie-band headwear is made of non-woven fabric, which is made by cutting and sewing. It is non-sterile and disposable.
Copious International Inc.
SCN0B191-1
In Commercial Distribution

  • 14719882253604 ()
  • 04719882253607 ()
  • 04719882253591 ()


  • Surgical cap, single-use
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