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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 (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 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

Acrylic Spheres 20 mm, 3.6 cc - 10697660000357

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
11-320
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 3.6 Milliliter


  • Orbital sphere implant

Acrylic Spheres 18 mm, 2.8 cc - 10697660000340

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
11-318
Not in Commercial Distribution


  • Outer Diameter: 18 Millimeter
  • Total Volume: 2.8 Milliliter


  • Orbital sphere implant

Acrylic Spheres 16 mm, 2.1 cc - 10697660000333

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
11-316
Not in Commercial Distribution


  • Outer Diameter: 16 Millimeter
  • Total Volume: 2.1 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

Acrylic Spheres 12 mm, 1.1 cc - 10697660000319

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
11-312
Not in Commercial Distribution


  • Outer Diameter: 12 Millimeter
  • Total Volume: 1.1 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 (20 mm, 4.2 cc) - 10697660000258

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
11-220
Not in Commercial Distribution


  • Total Volume: 4.2 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant

Silicone Spheres (19 mm, 3.6 cc) - 10697660000234

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
11-219
Not in Commercial Distribution


  • Outer Diameter: 19 Millimeter
  • Total Volume: 3.6 Milliliter


  • Orbital sphere implant
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