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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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Red Etch 1.2 cc syringe
ORTHOSOURCE
567-040
In Commercial Distribution

  • D911557040503 ()
  • D9115670400 ()
  • D911567040202 ()
  • D91156704041 ()


  • Dental etching solution
The product is a single use navigated suction instrument for image guided surgical procedures. The instruments are intended as an aid for locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0131042 ()
  • EFIAE0131041 ()
  • EFIAE0131043 ()
  • EFIAE0131044 ()


  • ENT stereotactic surgery system
The product FlexPointer 1.5 single use is navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0130041 ()
  • EFIAE0130042 ()
  • EFIAE0130043 ()
  • EFIAE0130044 ()
E 01 3004

  • ENT stereotactic surgery system
The ERG-Jet is a contact lens for performing an electroretinogram, or ERG, provocated by light stimulation of the retina in either humans or animals. The electrode is made of a gold ring just a few angstroms (10-10 meter) thick, which can be safely placed in contact with the cornea using a viscous conductive liquid.
Fabrinal SA
F06
In Commercial Distribution

  • EFABF061 ()
  • EFABF062 ()
  • EFAB0612 ()
  • EFABF063 ()

  • Electrical resistance: approx. 12 Ohms
  • Light transmission: 91.4%
  • Neutral optic quality
  • Female connection: DIN 1.50 Millimeter
  • Radius of curvature: 7.90 Millimeter
  • Outer Diameter: 12 Millimeter


  • Electroretinograph electrode
VPS Putty Fast Set 300ml. each Base & Catalyst - MARK3 EU
CARGUS INTERNATIONAL, INC
1161
In Commercial Distribution

  • D796116110 ()
  • D79611612 ()
  • D79611613 ()
  • D79611614 ()


  • Silicone dental impression material
VPS Putty Regular Set 300ml. each Base & Catalyst - MARK3 EU
CARGUS INTERNATIONAL, INC
1160
In Commercial Distribution

  • D79611601 ()
  • D79611602 ()
  • D79611603 ()
  • D79611604 ()


  • Silicone dental impression material
eXact VPS 380 Impression Material Monophase Regular Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
1153
In Commercial Distribution

  • D7961153 ()
  • D79611531 ()
  • D79611532 ()
  • D79611533 ()
  • D79611534 ()
1153

  • Silicone dental impression material
Alginate Alternative 380 Fast Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
9013
In Commercial Distribution

  • D7969013 ()
  • D79690131 ()
  • D79690132 ()
  • D79690133 ()
  • D79690134 ()
9013

  • Silicone dental impression material
Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of the MES 9000 allows you to purchase any combination of modules and expand as your practice grows. The MES 9000 --- the modular system that enables you to do a complete, integrated evaluation with objective documentation that supports your diagnosis.
MYOTRONICS NOROMED, INC
N9000M
In Commercial Distribution

  • D792N91500 ()
  • D792N9000M0 ()
  • D792N92000 ()
  • D792N9200S0 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
Flo2Max 5-in-1 Oxygen Mask, Child
B.L.S. Systems Limited
6110
In Commercial Distribution

  • B00266107 ()
  • B00261100 ()
  • B00261109 ()
  • B00261107 ()

  • Child
6110

  • Non-rebreathing oxygen face mask
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