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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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SONICflex prep CAD/CAM No. 34 (A) mesial - EKAV100619770

This is a medical device.
KaVo Dental GmbH
1.006.1977
In Commercial Distribution

  • EKAV100619770 ()
prep CAD CAM No 34 A mesial

  • Ultrasonic dental scaling/debridement system

SONICflex micro Tip No. 33 (A) - EKAV100619750

This is a medical device.
KaVo Dental GmbH
1.006.1975
In Commercial Distribution

  • EKAV100619750 ()
micro Tip No 33 A

  • Ultrasonic dental scaling/debridement system

SONICflex micro Tip No. 32 (A) - EKAV100619730

This is a medical device.
KaVo Dental GmbH
1.006.1973
In Commercial Distribution

  • EKAV100619730 ()
micro Tip No 32 A

  • Ultrasonic dental scaling/debridement system

SONICflex micro Tip No. 28 (A) - EKAV100619650

This is a medical device.
KaVo Dental GmbH
1.006.1965
In Commercial Distribution

  • EKAV100619650 ()
micro Tip No 28 A

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 27 (A) - EKAV100619630

This is a medical device.
KaVo Dental GmbH
1.006.1963
In Commercial Distribution

  • EKAV100619630 ()
rootplaner Tip No 27 A

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 26 (A) - EKAV100619610

This is a medical device.
KaVo Dental GmbH
1.006.1961
In Commercial Distribution

  • EKAV100619610 ()
rootplaner Tip No 26 A

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 25 (A) - EKAV100619590

This is a medical device.
KaVo Dental GmbH
1.006.1959
In Commercial Distribution

  • EKAV100619590 ()
rootplaner Tip No 25 A

  • Ultrasonic dental scaling/debridement system

SONICflex rootplaner Tip No. 24 (A) - EKAV100619570

This is a medical device.
KaVo Dental GmbH
1.006.1957
In Commercial Distribution

  • EKAV100619570 ()
rootplaner Tip No 24 A

  • Ultrasonic dental scaling/debridement system

SONICflex paro Tip No. 62 (A) - EKAV100619360

This is a medical device.
KaVo Dental GmbH
1.006.1936
In Commercial Distribution

  • EKAV100619360 ()
paro Tip No 62 A

  • Ultrasonic dental scaling/debridement system

SONICflex paro Tip No. 60 (A) - EKAV100619340

This is a medical device.
KaVo Dental GmbH
1.006.1934
In Commercial Distribution

  • EKAV100619340 ()
paro Tip No 60 A

  • Dental surgical power tool motor, pneumatic

EXPERTtorque Mini LUX E677 LN - EKAV100601000

This is a medical device.
KaVo Dental GmbH
1.006.0100
In Commercial Distribution

  • EKAV100601000 ()
E677 LN

  • Dental surgical power tool motor, pneumatic

SONICflex scaler Tip No. 6 (A) - EKAV100589500

This is a medical device.
KaVo Dental GmbH
1.005.8950
In Commercial Distribution

  • EKAV100589500 ()
scaler Tip No 6 A

  • Ultrasonic dental scaling/debridement system

SONICflex scaler Tip No. 5 (A) - EKAV100589490

This is a medical device.
KaVo Dental GmbH
1.005.8949
In Commercial Distribution

  • EKAV100589490 ()
scaler Tip No 5 A

  • Ultrasonic dental scaling/debridement system

ARCUS digma USB - EKAV100523010

This is a medical device.
KaVo Dental GmbH
1.005.2301
In Commercial Distribution

  • EKAV100523010 ()
NA

  • Facebow

InBody - 08809209591980

This is a Handheld Dynamometer
InBody Co., Ltd.
InGrip(IB-HGSm)
In Commercial Distribution

  • 08809209591980 ()


  • Hand dynamometer/pinchmeter, electronic

Gyrus ACMI - 00821925024137

VOKOVIC I-S JOINT REPLACEMENT PLASTIPORE
Gyrus ACMI, LLC
912986
Not in Commercial Distribution

  • 00821925024137 ()


  • Ossicular prosthesis, partial

Millennium - 00190776166113

PIERCE Cheek Retractor . Blade is
Avalign Technologies, Inc.
1-24160
In Commercial Distribution

  • 00190776166113 ()


  • Hand-held surgical retractor, reusable

iClean - 26974488990062

The breaking point is 90mm.
Huachenyang (Shenzhen) Technology Co., Ltd
CY-96000
In Commercial Distribution

  • 36974488990069 ()
  • 26974488990062 ()
  • 16974488990065 ()


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

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

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

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

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

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

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 - 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 - 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 - 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 - 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 - 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
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