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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 - 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

Lumecca I - 07290016633955

Lumecca-I is an IPL applicator
INMODE M.D LTD
AG610797A
In Commercial Distribution

  • 07290016633955 ()
AG610797A

  • Multi-modality skin surface treatment system

iClean - 16974488990096

The breaking point is 80mm.
Huachenyang (Shenzhen) Technology Co., Ltd
CY-96000
In Commercial Distribution

  • 26974488990093 ()
  • 16974488990096 ()
  • 06974488990099 ()


  • General-purpose absorbent tip applicator/swab, single-use

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

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

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

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

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

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

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

Copioumed - 04719882253584

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.
SCN0G181-1
In Commercial Distribution

  • 14719882253581 ()
  • 04719882253584 ()
  • 04719882253577 ()


  • Surgical cap, single-use

Copioumed - 04719882253560

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.
SCN0B181-1
In Commercial Distribution

  • 14719882253567 ()
  • 04719882253560 ()
  • 04719882253553 ()


  • Surgical cap, single-use

Luminscan(TM) Disposable Imaging Kit - 06932503570107

The diameter of the balloon is 20mm, the effective length is 80mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Micro-Tech (Nanjing) Co., Ltd.
BOP-20-80-25-7
In Commercial Distribution

  • 16932503570104 ()
  • 06932503570107 ()
  • 26932503570101 ()

  • Balloon Diameter: 20 Millimeter
  • Balloon Length: 80 Millimeter
  • Length: 250 Centimeter


  • Coronary optical coherence tomography system

Luminscan(TM) Disposable Imaging Kit - 06932503570084

The diameter of the balloon is 20mm, the effective length is 30mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Micro-Tech (Nanjing) Co., Ltd.
BOP-20-30-25-7
In Commercial Distribution

  • 16932503570081 ()
  • 06932503570084 ()
  • 26932503570088 ()

  • Balloon Diameter: 20 Millimeter
  • Balloon Length: 30 Millimeter
  • Length: 250 Centimeter


  • Coronary optical coherence tomography system

Luminscan(TM) Disposable Imaging Kit - 06932503570077

The diameter of the balloon is 18mm, the effective length is 80mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Micro-Tech (Nanjing) Co., Ltd.
BOP-18-80-25-7
In Commercial Distribution

  • 16932503570074 ()
  • 06932503570077 ()
  • 26932503570071 ()

  • Balloon Diameter: 18 Millimeter
  • Balloon Length: 80 Millimeter
  • Length: 250 Centimeter


  • Coronary optical coherence tomography system

Luminscan(TM) Disposable Imaging Kit - 06932503570053

The diameter of the balloon is 18mm, the effective length is 30mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Micro-Tech (Nanjing) Co., Ltd.
BOP-18-30-25-7
In Commercial Distribution

  • 16932503570050 ()
  • 06932503570053 ()
  • 26932503570057 ()

  • Balloon Diameter: 18 Millimeter
  • Balloon Length: 30 Millimeter
  • Length: 250 Centimeter


  • Coronary optical coherence tomography system

Luminscan(TM) Disposable Imaging Kit - 06932503570039

The diameter of the balloon is 16mm, the effective length is 55mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Micro-Tech (Nanjing) Co., Ltd.
BOP-16-55-25-7
In Commercial Distribution

  • 16932503570036 ()
  • 06932503570039 ()
  • 26932503570033 ()

  • Balloon Diameter: 16 Millimeter
  • Balloon Length: 55 Millimeter
  • Length: 250 Centimeter


  • Coronary optical coherence tomography system

Luminscan(TM) Disposable Imaging Kit - 06932503570091

The diameter of the balloon is 20mm, the effective length is 55mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Micro-Tech (Nanjing) Co., Ltd.
BOP-20-55-25-7
In Commercial Distribution

  • 16932503570098 ()
  • 06932503570091 ()
  • 26932503570095 ()

  • Balloon Diameter: 20 Millimeter
  • Balloon Length: 55 Millimeter
  • Length: 250 Centimeter


  • Coronary optical coherence tomography system

Luminscan(TM) Disposable Imaging Kit - 06932503570060

The diameter of the balloon is 18mm, the effective length is 55mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Micro-Tech (Nanjing) Co., Ltd.
BOP-18-55-25-7
In Commercial Distribution

  • 16932503570067 ()
  • 06932503570060 ()
  • 26932503570064 ()

  • Balloon Diameter: 18 Millimeter
  • Balloon Length: 55 Millimeter
  • Length: 250 Centimeter


  • Coronary optical coherence tomography system

Luminscan(TM) Disposable Imaging Kit - 06932503570046

The diameter of the balloon is 16mm, the effective length is 80mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Micro-Tech (Nanjing) Co., Ltd.
BOP-16-80-25-7
In Commercial Distribution

  • 16932503570043 ()
  • 06932503570046 ()
  • 26932503570040 ()

  • Balloon Diameter: 16 Millimeter
  • Balloon Length: 80 Millimeter
  • Length: 250 Centimeter


  • Coronary optical coherence tomography system

Luminscan(TM) Disposable Imaging Kit - 06932503570022

The diameter of the balloon is 16mm, the effective length is 30mm, the outer diameter of the Balloon catheter is 7Fr, and the length of the probe is 2500mm
Micro-Tech (Nanjing) Co., Ltd.
BOP-16-30-25-7
In Commercial Distribution

  • 16932503570029 ()
  • 06932503570022 ()
  • 26932503570026 ()

  • Balloon Diameter: 16 Centimeter
  • Balloon Length: 30 Millimeter
  • Length: 250 Centimeter


  • Coronary optical coherence tomography system

Sterile Hydro-Slide Guidewire - 06932503510165

The maximum diameter is 0.035inch,working length is 4500mm,color is yellow & blue,Straight tip,Normal shaft,Wave surface, 0.018inch tip tube
Micro-Tech (Nanjing) Co., Ltd.
MTN-BM-89/45-A-W-1
In Commercial Distribution

  • 16932503510162 ()
  • 06932503510165 ()
  • 26932503510169 ()

  • Guidewire Diameter: 0.035 Inch
  • Guidewire Length: 4500 Centimeter


  • Gastro-urological guidewire, single-use

Sterile Hydro-Slide Guidewire - 06932503510141

The maximum diameter is 0.035inch,working length is 2600mm,color is yellow & blue,Straight tip,Normal shaft,Wave surface, 0.018inch tip tube
Micro-Tech (Nanjing) Co., Ltd.
MTN-BM-89/26-A-W-1
In Commercial Distribution

  • 16932503510148 ()
  • 06932503510141 ()
  • 26932503510145 ()

  • Guidewire Diameter: 0.035 Inch
  • Guidewire Length: 2600 Centimeter


  • Gastro-urological guidewire, single-use

Sterile Hydro-Slide Guidewire - 06932503510134

The maximum diameter is 0.035inch,working length is 2600mm,color is yellow & blue,Straight tip,Normal shaft,Wave surface, 0.025inch tip tube
Micro-Tech (Nanjing) Co., Ltd.
MTN-BM-89/26-A-W
In Commercial Distribution

  • 16932503510131 ()
  • 06932503510134 ()
  • 26932503510138 ()

  • Guidewire Diameter: 0.035 Inch
  • Guidewire Length: 2600 Centimeter


  • Gastro-urological guidewire, single-use

Sterile Hydro-Slide Guidewire - 06932503510158

The maximum diameter is 0.035inch,working length is 4500mm,color is yellow & blue,Straight tip,Normal shaft,Wave surface,0.025inch tip tube
Micro-Tech (Nanjing) Co., Ltd.
MTN-BM-89/45-A-W
In Commercial Distribution

  • 16932503510155 ()
  • 06932503510158 ()
  • 26932503510152 ()

  • Guidewire Diameter: 0.035 Inch
  • Guidewire Length: 4500 Centimeter


  • Gastro-urological guidewire, single-use

PANTA® - 10381780042747

The basis is part of the container which product number is 519900ND and that is used for transport and sterilization of instruments.
NEWDEAL
519910ND
Not in Commercial Distribution

  • M248519910ND1 ()
  • 10381780042747 ()


  • Device sterilization/disinfection container, reusable

B-BOP® - 10381780042396

The basis is part of the container which product number is 189900ND and that is used for transport and sterilization of instruments.
NEWDEAL
189910ND
Not in Commercial Distribution

  • M248189910ND1 ()
  • 10381780042396 ()


  • Device sterilization/disinfection container, reusable

PANTA® - 10381780042778

The lid is part of the container which product number is 519900ND and that is used for transport and sterilization of instruments.
NEWDEAL
519920ND
In Commercial Distribution

  • M248519920ND1 ()
  • 10381780042778 ()


  • Device sterilization/disinfection container, reusable

Integra® Total Foot System - 10381780119005

The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium and is a non-locking screw.
Ascension Orthopedics, Inc.
2837150
In Commercial Distribution

  • 10381780119005 ()
  • M26828371501 ()

  • 50 mm L x 2.7 mm dia
2837150

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Integra® Total Foot System - 10381780118985

The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium and is a non-locking screw.
Ascension Orthopedics, Inc.
2837140
In Commercial Distribution

  • 10381780118985 ()
  • M26828371401 ()

  • 40 mm L x 2.7 mm dia
2837140

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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