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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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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
1001-01014-UN
In Commercial Distribution

  • 03615220003617 ()


  • Electroencephalographic electrode cap, single-use
SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of dental piosthesis and endodontics by means of ultrasound vibrations produced by a piezoelectric transducer.
SILFRADENT SRL
SURGYBONE na
In Commercial Distribution

  • 08056093310016 ()
  • 18056093310013 ()


  • Ultrasonic dental scaling/debridement system
RePlay Hemostasis Clip, 18 mm
DIVERSATEK HEALTHCARE, INC.
1170-03
In Commercial Distribution

  • 10816734023171 ()
  • 00816734023174 ()
  • 20816734023178 ()
1170-03

  • Gastrointestinal endoscopic clip, short-term
Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-11
In Commercial Distribution

  • 10816734021610 ()
  • 00816734021613 ()

  • Length: 230 Centimeter
  • Width: 25 Millimeter
1180-11

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-10
In Commercial Distribution

  • 10816734021603 ()
  • 00816734021606 ()

  • Width: 15 Millimeter
  • Length: 230 Centimeter
1180-10

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-04
In Commercial Distribution

  • 10816734021597 ()
  • 00816734021590 ()

  • Length: 230 Centimeter
  • Width: 32 Millimeter
1180-04

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-03
In Commercial Distribution

  • 00816734021583 ()
  • 10816734021580 ()

  • Width: 25 Millimeter
  • Length: 230 Centimeter
1180-03

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-02
In Commercial Distribution

  • 10816734021573 ()
  • 00816734021576 ()

  • Length: 230 Centimeter
  • Width: 15 Millimeter
1180-02

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Lasso Polypectomy Snare
DIVERSATEK HEALTHCARE, INC.
1180-01
In Commercial Distribution

  • 10816734021566 ()
  • 00816734021569 ()

  • Width: 10 Millimeter
  • Length: 230 Centimeter
1180-01

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
RePlay Hemostasis Clip, 11mm span
DIVERSATEK HEALTHCARE, INC.
1170-01
In Commercial Distribution

  • 10816734021481 ()
  • 00816734021484 ()

  • Length: 230 Centimeter
  • Outer Diameter: 2.3 Millimeter
  • Width: 11 Millimeter
1170-01

  • Gastrointestinal endoscopic clip, short-term
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