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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 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 eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14151
In Commercial Distribution

  • 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
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

  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant
MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80014
In Commercial Distribution

  • 07613252088585 ()

  • Diameter: 22.0 Millimeter
80014

  • Orbital sphere implant
MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80012
In Commercial Distribution

  • 07613252088578 ()

  • Diameter: 20.0 Millimeter
80012

  • Orbital sphere implant
MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80008
In Commercial Distribution

  • 07613252088561 ()

  • Diameter: 16.0 Millimeter
80008

  • Orbital sphere implant
Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6322
In Commercial Distribution

  • 07613252088424 ()

  • Diameter: 22.0 Millimeter
6322

  • Orbital sphere implant
MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80010
In Commercial Distribution

  • 07613252084044 ()

  • Diameter: 18.0 Millimeter
80010

  • Orbital sphere implant
Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6327
In Commercial Distribution

  • 07613252083405 ()

  • Diameter: 18.0 Millimeter
6327

  • Orbital sphere implant
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