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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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Silicone Spheres (18 mm, 3.1 cc) - M8721121807

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
11-218
Not in Commercial Distribution

  • M8721121807 ()

  • Outer Diameter: 18 Millimeter
  • Total Volume: 3.1 Milliliter


  • Orbital sphere implant

Silicone Spheres (16 mm, 2.1 cc) - M8721121605

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
11-216
Not in Commercial Distribution

  • M8721121605 ()

  • Outer Diameter: 16 Millimeter
  • Total Volume: 2.1 Milliliter


  • Orbital sphere implant

Silicone Spheres (15 mm, 1.8 cc) - M8721121504

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

Silicone Spheres (14 mm , 1.4 cc) - M8721121403

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

Silicone Spheres (12 mm, 0.9 cc) - M8721121201

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

Acrylic Spheres 14 mm, 1.5 cc - 10697660000326

Acrylic 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 ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-314
Not in Commercial Distribution


  • Outer Diameter: 14 Millimeter
  • Total Volume: 1.5 Milliliter


  • Orbital sphere implant

Silicone Spheres (22 mm, 5.6 cc) - 10697660000296

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 silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-222
Not in Commercial Distribution


  • Outer Diameter: 22 Millimeter
  • Total Volume: 5.6 Milliliter


  • Orbital sphere implant

Silicone Spheres (15 mm, 1.8 cc) - 10697660000173

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 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


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


  • Orbital sphere implant

Silicone Spheres (14 mm , 1.4 cc) - 10697660000159

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 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


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


  • Orbital sphere implant

Acrylic Spheres 22 mm, 5.7 cc - 10697660000364

Acrylic 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 ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-322
Not in Commercial Distribution


  • Outer Diameter: 22 Millimeter
  • Total Volume: 5.7 Milliliter


  • Orbital sphere implant
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