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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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HydroFill Helical - 00811425026731

V-Trak
MICROVENTION INC.
100202HFIL-V-A
In Commercial Distribution

  • 00811425026731 ()

  • 2 mm x 2 cm
100202HFIL-V

  • Neurovascular embolization coil

HydroFill Helical - 00811425020272

V-Trak
MICROVENTION INC.
100202HFIL-V-N
In Commercial Distribution

  • 00811425020272 ()

  • 2 mm x 2 cm
100202HFIL-V

  • Neurovascular embolization coil

HydroFrame Framing Coil - 00811425020227

V-Trak
MICROVENTION INC.
100202HFRM-V-N
In Commercial Distribution

  • 00811425020227 ()

  • 2 mm x 2 cm
100202HFRM-V

  • Neurovascular embolization coil

HydroSoft Helical - 00811425020142

V-Trak
MICROVENTION INC.
100202H2HS-V-N
In Commercial Distribution

  • 00811425020142 ()

  • 2 mm x 2 cm
100202H2HS-V

  • Neurovascular embolization coil

Neuronaute IceCap 2 Small - 03615220003792

The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.
BIOSERENITY MEDICAL DEVICES GROUP
1001-01015-UN
In Commercial Distribution

  • 03615220003792 ()


  • Electroencephalographic electrode cap, single-use

KNEE COIL N.2 - 08056304453259

Coil for E-scan, Opera
ESAOTE SPA
9101824000
In Commercial Distribution

  • 08056304453259 ()


  • MRI system coil, radio-frequency

COIL N.2 LARGE - 08056304453167

Coil for Artoscan
ESAOTE SPA
9101034000
In Commercial Distribution

  • 08056304453167 ()


  • MRI system coil, radio-frequency

KNEE COIL N. 2 - 08056304452696

Coil for G-scan
ESAOTE SPA
9101824100
In Commercial Distribution

  • 08056304452696 ()


  • MRI system coil, radio-frequency

KNEE COIL N. 2 - 08056304452429

Coil for S-scan
ESAOTE SPA
9101824200
In Commercial Distribution

  • 08056304452429 ()


  • MRI system coil, radio-frequency

truSculpt 2 RF handpiece - 00816722022479

truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device
CUTERA, INC.
truSculpt 2 RF handpiece
In Commercial Distribution

  • 00816722022479 ()


  • Radio-frequency skin contouring system applicator, monopolar
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