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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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Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14153
In Commercial Distribution

  • B091141531 ()
  • B091141530 ()

  • Outer Diameter: 16 Millimeter
14153

  • Orbital sphere implant
Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14152
In Commercial Distribution

  • B091141521 ()
  • B091141520 ()

  • Outer Diameter: 14 Millimeter
14152

  • Orbital sphere implant
Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14151
In Commercial Distribution

  • B091141511 ()
  • B091141510 ()

  • Outer Diameter: 12 Millimeter
14151

  • Orbital sphere implant
Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14150
In Commercial Distribution

  • B091141501 ()
  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant
materials for inlays, onlays, crowns and bridges
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
626354
In Commercial Distribution

  • DIVO6263541 ()
  • DIVO6263540 ()
626354

  • Dental implant suprastructure, permanent, preformed
materials for inlays, onlays, crowns and bridges
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
626353
In Commercial Distribution

  • DIVO6263531 ()
  • DIVO6263530 ()
626353

  • Dental implant suprastructure, permanent, preformed
materials for inlays, onlays, crowns and bridges
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
626352
In Commercial Distribution

  • DIVO6263521 ()
  • DIVO6263520 ()
626352

  • Dental implant suprastructure, permanent, preformed
materials for inlays, onlays, crowns and bridges
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
626351
In Commercial Distribution

  • DIVO6263511 ()
  • DIVO6263510 ()
626351

  • Dental implant suprastructure, permanent, preformed
materials for inlays, onlays, crowns and bridges
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
626350
In Commercial Distribution

  • DIVO6263501 ()
  • DIVO6263500 ()
626350

  • Dental implant suprastructure, permanent, preformed
materials for inlays, onlays, crowns and bridges
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
626349
In Commercial Distribution

  • DIVO6263491 ()
  • DIVO6263490 ()
626349

  • Dental implant suprastructure, permanent, preformed
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