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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Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-215V
Not in Commercial Distribution

  • M87211215V91 ()

  • Total Volume: 1.8 Milliliter
  • Outer Diameter: 15 Millimeter


  • Orbital sphere implant
Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-215
Not in Commercial Distribution

  • M8721121504 ()

  • Outer Diameter: 15 Millimeter
  • Total Volume: 1.8 Milliliter


  • Orbital sphere implant
Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-214V
Not in Commercial Distribution

  • M87211214V90 ()

  • Total Volume: 1.4 Milliliter
  • Outer Diameter: 14 Millimeter


  • Orbital sphere implant
Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-214
Not in Commercial Distribution

  • M8721121403 ()

  • Total Volume: 1.4 Milliliter
  • Outer Diameter: 14 Millimeter


  • Orbital sphere implant
Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-212V
Not in Commercial Distribution

  • M87211212V9 ()

  • Outer Diameter: 12 Millimeter
  • Total Volume: 0.9 Milliliter


  • Orbital sphere implant
Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-212
Not in Commercial Distribution

  • M8721121201 ()

  • Outer Diameter: 12 Millimeter
  • Total Volume: 0.9 Milliliter


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

  • 07613252083405 ()

  • Diameter: 18.0 Millimeter
6327

  • Orbital sphere implant
Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6326
In Commercial Distribution

  • 07613252083399 ()

  • Diameter: 16.0 Millimeter
6326

  • Orbital sphere implant
Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6316
In Commercial Distribution

  • 07613252083382 ()

  • Diameter: 14.0 Millimeter
6316

  • 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
6317
In Commercial Distribution

  • 07613252083375 ()

  • Diameter: 20.0 Millimeter
6317

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14356
Not in Commercial Distribution

  • B091143560 ()

  • Outer Diameter: 22 Millimeter
14356

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14355
Not in Commercial Distribution

  • B091143550 ()

  • Outer Diameter: 20 Millimeter
14355

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14354
Not in Commercial Distribution

  • B091143540 ()

  • Outer Diameter: 18 Millimeter
14354

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14353
Not in Commercial Distribution

  • B091143530 ()

  • Outer Diameter: 16 Millimeter
14353

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14352
Not in Commercial Distribution

  • B091143520 ()

  • Outer Diameter: 14 Millimeter
14352

  • Orbital sphere implant
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