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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 DEKA AGAIN PRO family is a medical laser family equipped with Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user repleaceable optical fiber with a wider range of intercheangeable, quick release laser handpieces with electronic spot recognition.
DEKA M.E.L.A. SRL
M126AB1
In Commercial Distribution

  • 08034108512532 ()


  • Multi-modality skin surface treatment system
The DEKA AGAIN PRO family is a medical laser family equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user repleaceable optical fiber with a wider range of intercheangeable, quick release laser handpieces with electronic spot recognition.
DEKA M.E.L.A. SRL
M126AA1
In Commercial Distribution

  • 08034108512525 ()


  • Multi-modality skin surface treatment system
ATTIVA is a Radiofrequency (RF) System (generator, electrodes/handpieces and accessories) indicated for treatments based on the emission of electromagnetic waves that lead to a rise of internal temperature of tissues involved in the treatment for electrocoagulation and hemostasis. ATTIVA device can be used on adult patients only. It comprises of a base unit, activation pedal, ground pad (K203494), endodermic handpiece, thermal camera (K033967) and monitor, and blunt cannulas and RF electrodes.
ITALIAN ENGINEERING SRL
MD01
In Commercial Distribution

  • 08055510890087 ()

  • Weight: 5.8 Kilogram
  • Length: 38.5 Centimeter
  • Height: 10 Centimeter
  • Width: 20.5 Centimeter


  • Percutaneous radio-frequency ablation system generator
Imaging System
LIGHTLAB IMAGING, INC.
900-700-00
In Commercial Distribution

  • 00183739000630 ()
900-700-00

  • Coronary optical coherence tomography system
Breast Grid (User-Sterilized)
Philips Medical Systems Nederland B.V.
989603214224
In Commercial Distribution

  • 00884838120211 ()
  • 00884838118799 ()


  • Needle guide, single-use
The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Philips Healthcare (Suzhou) Co., Ltd.
728144
In Commercial Distribution

  • 00884838105508 ()
728144

  • Full-body CT system
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
712214
Not in Commercial Distribution

  • 00884838064751 ()
712214

  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
989701001012
Not in Commercial Distribution

  • 00884838064737 ()
712213

  • Stationary basic diagnostic x-ray system, digital
Biopsy Grid (User-sterilized)
Philips Ds North America LLC
98960321422
In Commercial Distribution

  • 00884838083615 ()


  • MRI system coil, radio-frequency
Biopsy Grid
Philips Ds North America LLC
98960321420
In Commercial Distribution

  • 00884838083608 ()


  • MRI system coil, radio-frequency
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