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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 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
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
Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation
Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation
Autoclave Pouches 5 1/4" x 10", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH514105 ()
  • D832POH51410 ()
  • D832POH514101 ()
  • D832POH514102 ()
POH514-10

  • Sterilization packaging, single-use
Autoclave Pouches 4 1/4" x 12", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH414125 ()
  • D832POH41412 ()
  • D832POH414121 ()
  • D832POH414122 ()
POH414-12

  • Sterilization packaging, single-use
Autoclave Pouches 3 1/2" x 9", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH31295 ()
  • D832POH3129 ()
  • D832POH31291 ()
  • D832POH31292 ()
POH312-9

  • Sterilization packaging, single-use
Autoclave Pouches 2" x 9", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH295 ()
  • D832POH29 ()
  • D832POH291 ()
  • D832POH292 ()
POH2-9

  • Sterilization packaging, single-use
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