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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02 pieces sets for embryo transfer
LABORATOIRE CCD
ECHOGYN ® EMBRYOVIEW M 18 CM
In Commercial Distribution

  • 03700111425378 ()
  • 03700111400375 ()

  • Outer Diameter: 0.157 Centimeter
  • Catheter Length: 24.4 Centimeter
1325901

  • Assisted reproduction transfer catheter trial
02 pieces sets for trial embryo transfer
LABORATOIRE CCD
ECHOGYN® EMBRYOVIEW M MOCK 23 CM
In Commercial Distribution

  • 03700111425361 ()
  • 03700111400368 ()

  • Outer Diameter: 0.157 Centimeter
  • Catheter Length: 29.4 Centimeter
1325801

  • Assisted reproduction transfer catheter trial
02 pieces sets for embryo transfer
LABORATOIRE CCD
ECHOGYN®EMBRYOVIEW M 23 CM
In Commercial Distribution

  • 03700111425354 ()
  • 03700111400351 ()

  • Catheter Length: 29.4 Centimeter
  • Outer Diameter: 0.157 Centimeter
1325701

  • Assisted reproduction transfer catheter trial
02 pieces sets for trial embryo transfer
LABORATOIRE CCD
CLASSIC ULTRASOFT MOCK 23 CM
In Commercial Distribution

  • 03700111425309 ()
  • 03700111400306 ()

  • Outer Diameter: 0.156 Centimeter
  • Catheter Length: 29.4 Centimeter
1324601

  • Assisted reproduction transfer catheter trial
02 pieces sets for embryo transfer
LABORATOIRE CCD
CLASSIC ULTRASOFT 23 CM
In Commercial Distribution

  • 03700111425293 ()
  • 03700111400290 ()

  • Outer Diameter: 0.156 Centimeter
  • Catheter Length: 29.4 Centimeter
1324501

  • Assisted reproduction transfer catheter trial
02 pieces sets for embryo transfer
LABORATOIRE CCD
FRYDMAN®ULTRASOFT ECHO
In Commercial Distribution

  • 03700111425279 ()
  • 03700111400276 ()

  • Outer Diameter: 0.155 Centimeter
  • Catheter Length: 25.5 Centimeter
1324301

  • Assisted reproduction transfer catheter trial
02 pieces sets for embryo transfer
LABORATOIRE CCD
FRYDMAN® ULTRASOFT
In Commercial Distribution

  • 03700111425262 ()
  • 03700111400269 ()

  • Outer Diameter: 0.155 Centimeter
  • Catheter Length: 25.5 Centimeter
1324201

  • Assisted reproduction transfer catheter trial
02 pieces sets for embryo transfer
LABORATOIRE CCD
ULTRASOFT FRYDMAN® SET MOCK ECHO
In Commercial Distribution

  • 03700111425224 ()
  • 03700111400221 ()

  • Outer Diameter: 0.155 Centimeter
  • Catheter Length: 26 Centimeter
1323801

  • Assisted reproduction transfer catheter trial
02 pieces sets for embryo transfer
LABORATOIRE CCD
ULTRASOFT FRYDMAN ® SET MOCK
In Commercial Distribution

  • 03700111425217 ()
  • 03700111400214 ()

  • Outer Diameter: 0.155 Centimeter
  • Catheter Length: 26 Centimeter
1323701

  • Assisted reproduction transfer catheter trial
02 pieces sets for embryo transfer
LABORATOIRE CCD
ULTRASOFT FRYDMAN ® SET ECHO
In Commercial Distribution

  • 03700111425194 ()
  • 03700111400191 ()

  • Outer Diameter: 0.155 Centimeter
  • Catheter Length: 26 Centimeter
1323501

  • Assisted reproduction transfer catheter trial
02 pieces sets for embryo transfer
LABORATOIRE CCD
CLASSIC ULTRASOFT MOCK 18 CM
In Commercial Distribution

  • 03700111425149 ()
  • 03700111400146 ()

  • Catheter Length: 24.4 Centimeter
  • Outer Diameter: 0.155 Centimeter
1323001

  • Assisted reproduction transfer catheter trial
Catheter for embryo transfer trial
LABORATOIRE CCD
MOCK CATHETER
In Commercial Distribution

  • 03700111425132 ()
  • 03700111400139 ()

  • Catheter Length: 20.7 Centimeter
  • Outer Diameter: 0.16 Centimeter
1322901

  • Assisted reproduction transfer catheter/set
03 pieces sets for embryo transfer
LABORATOIRE CCD
ULTRASOFT FRYDMAN ® SET ECHO WITH GUIDE
In Commercial Distribution

  • 03700111425125 ()
  • 03700111400122 ()

  • Catheter Length: 26 Centimeter
  • Outer Diameter: 0.155 Centimeter
1322801

  • Assisted reproduction transfer catheter trial
02 pieces sets for embryo transfer
LABORATOIRE CCD
CLASSIC ULTRASOFT 18 CM
In Commercial Distribution

  • 03700111425101 ()
  • 03700111400108 ()

  • Catheter Length: 24.4 Centimeter
  • Outer Diameter: 0.155 Centimeter
1321301

  • Assisted reproduction transfer catheter trial
03 pieces sets for embryo transfer
LABORATOIRE CCD
STYLET FOR FRYDMAN® ULTRASOFT & FRYDMAN® ULTRASOFT echo
In Commercial Distribution

  • 03700111425095 ()
  • 03700111400092 ()

  • Outer Diameter: 0.16 Centimeter
  • Catheter Length: 20.100000000000001 Centimeter
1320701

  • Assisted reproduction transfer catheter/set
Catheter for embryo transfer
LABORATOIRE CCD
INVENTCATH ECO
In Commercial Distribution

  • 03700111425088 ()
  • 03700111400085 ()

  • Catheter Length: 22.4 Centimeter
  • Outer Diameter: 0.22 Centimeter
1320121

  • Assisted reproduction transfer catheter/set
03 pieces sets for embryo transfer
LABORATOIRE CCD
FRYDMAN ® SOFT WITH GUIDE
In Commercial Distribution

  • 03700111425040 ()
  • 03700111400047 ()

  • Outer Diameter: 0.16 Centimeter
  • Catheter Length: 26 Centimeter
1307000

  • Assisted reproduction transfer catheter trial
Catheter for embryo transfer
LABORATOIRE CCD
FRYDMAN® CLASSIC 5.5
In Commercial Distribution

  • 03700111425033 ()
  • 03700111400030 ()

  • Outer Diameter: 0.26 Centimeter
  • Catheter Length: 21.7 Centimeter
1306055

  • Assisted reproduction transfer catheter/set
Catheter for embryo transfer
LABORATOIRE CCD
FRYDMAN® CLASSIC 4.5
In Commercial Distribution

  • 03700111425026 ()
  • 03700111400023 ()

  • Outer Diameter: 0.26 Centimeter
  • Catheter Length: 20.7 Centimeter
1306045

  • Assisted reproduction transfer catheter/set
No Description
BODYCAP
P024-M
In Commercial Distribution

  • 03665810000168 ()


  • Continuous electronic patient thermometer, battery-powered
No Description
BODYCAP
P072
In Commercial Distribution

  • 03665810000083 ()


  • Continuous electronic patient thermometer, battery-powered
No Description
BODYCAP
P030-M
In Commercial Distribution

  • 03665810000045 ()


  • Continuous electronic patient thermometer, battery-powered
No Description
BODYCAP
P040-M_FCC
In Commercial Distribution

  • 03665810000038 ()


  • Continuous electronic patient thermometer, battery-powered
A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. Hardware reference: Lenovo Thinkcentre M70a
KOELIS
KURO-4000
In Commercial Distribution

  • 03665134000929 ()


  • Image segmentation application software
ProMap Lite is designed to display medical images of different modalities, prepare these images for an ultrasound-guided prostate procedure, and review the images and data generated during an ultrasound-guided prostate procedure.
KOELIS
KSOF-2602
In Commercial Distribution

  • 03665134000714 ()


  • Image segmentation application software
Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm
KOELIS
K2DLN00
In Commercial Distribution

  • 03665134000530 ()
  • 03665134000103 ()


  • General-purpose ultrasound imaging system
Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm
KOELIS
K2DAB00
In Commercial Distribution

  • 03665134000523 ()
  • 03665134000097 ()


  • General-purpose ultrasound imaging system
Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00
In Commercial Distribution

  • 03665134000516 ()
  • 03665134000080 ()


  • General-purpose ultrasound imaging system
Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology and gynecology applications. Frequencies: 4-9 MHz Field of view 146° Scanning angle 90° Radius 10 mm
KOELIS
K3DEC00-2
In Commercial Distribution

  • 03665134000509 ()
  • 03665134000073 ()


  • General-purpose ultrasound imaging system
Dental impression disinfectant
Cavex Holland B.V.
HT020
In Commercial Distribution

  • E241HT0200 ()

  • 1 pcs
HT020

  • Denture cleanser
Dental impression disinfectant
Cavex Holland B.V.
HA053
In Commercial Distribution

  • E241HA0530 ()

  • 1 pcs
HA053

  • Denture cleanser
Dental cleaning agent
Cavex Holland B.V.
HA003
In Commercial Distribution

  • E241HA0030 ()

  • 1 pcs
HA003

  • Denture cleanser
Dental Cement
Cavex Holland B.V.
CE090
In Commercial Distribution

  • E241CE0900 ()

  • 1 pcs
CE090

  • Temporary dental filling material
Dental Whitening Agent
Cavex Holland B.V.
BW090
In Commercial Distribution

  • E241BW0900 ()

  • 1 pcs
BW090

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW085
In Commercial Distribution

  • E241BW0850 ()

  • 1 pcs
BW085

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW080
In Commercial Distribution

  • E241BW0800 ()

  • 1 pcs
BW080

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW070
In Commercial Distribution

  • E241BW0700 ()

  • 1 pcs
BW070

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW060
In Commercial Distribution

  • E241BW0600 ()

  • 1 pcs
BW060

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW035
In Commercial Distribution

  • E241BW0350 ()

  • 1 pcs
BW035

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW030
In Commercial Distribution

  • E241BW0300 ()

  • 1 pcs
BW030

  • Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW015
In Commercial Distribution

  • E241BW0150 ()

  • 1 pcs
BW015

  • Dental bleaching agent
Dental Wax
Cavex Holland B.V.
BP055
In Commercial Distribution

  • E241BP0550 ()

  • 1 pcs
BP055

  • Dental base plate
Dental Wax
Cavex Holland B.V.
BP024
In Commercial Distribution

  • E241BP0240 ()

  • 1 pcs
BP024

  • Dental base plate
Dental Wax
Cavex Holland B.V.
BP004
In Commercial Distribution

  • E241BP0040 ()

  • 1 pcs
BP004

  • Dental base plate
Dental Wax
Cavex Holland B.V.
BL036
In Commercial Distribution

  • E241BL0360 ()

  • 1 pcs
BL036

  • Dental base plate
Dental Wax
Cavex Holland B.V.
BL060
In Commercial Distribution

  • E241BL0060 ()

  • 1 pcs
BL060

  • Dental base plate
Dental Alginate Impression material - accessories
Cavex Holland B.V.
AT321
In Commercial Distribution

  • E241AT3210 ()

  • 1 pcs
AT321

  • Alginate dental impression material
Dental Alginate Impression material - accessories
Cavex Holland B.V.
AT260
In Commercial Distribution

  • E241AT2600 ()

  • 1 pcs
AT260

  • Alginate dental impression material
Dental Alginate Impression material - accessories
Cavex Holland B.V.
AT240
In Commercial Distribution

  • E241AT2400 ()

  • 1 pcs
AT240

  • Alginate dental impression material
Dental Alginate Impression material - accessories
Cavex Holland B.V.
AT076
In Commercial Distribution

  • E241AT0760 ()

  • 1 pcs
AT076

  • Alginate dental impression material
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