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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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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
11-220V
Not in Commercial Distribution

  • M87211220V9 ()

  • Outer Diameter: 20 Millimeter
  • Total Volume: 4.2 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
11-219V
Not in Commercial Distribution

  • M87211219V95 ()

  • Total Volume: 3.6 Milliliter
  • Outer Diameter: 19 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
11-216V
Not in Commercial Distribution

  • M87211216V92 ()

  • Outer Diameter: 16 Millimeter
  • Total Volume: 2.1 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
11-215V
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
11-214V
Not in Commercial Distribution

  • M87211214V90 ()

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


  • Orbital sphere implant
GUTTA PERCHA POINTS (100/box) Type: PT Taper, Size: F3; For more information: https://www.scottsdental.com/catalog/product/view/id/23535/s/tapered-gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9192
In Commercial Distribution

  • D77810391920 ()
  • D77810391921 ()
103-9192

  • Natural gutta-percha
GUTTA PERCHA POINTS (100/box) Type: PT Taper, Size: F1; For more information: https://www.scottsdental.com/catalog/product/view/id/23535/s/tapered-gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9188
In Commercial Distribution

  • D77810391880 ()
  • D77810391881 ()
103-9188

  • Natural gutta-percha
GUTTA PERCHA POINTS (120/box) Size: 110; For more information: https://www.scottsdental.com/catalog/product/view/id/23534/s/gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9031
In Commercial Distribution

  • D77810390310 ()
  • D77810390311 ()
103-9031

  • Natural gutta-percha
GUTTA PERCHA POINTS (120/box) Size: 90; For more information: https://www.scottsdental.com/catalog/product/view/id/23534/s/gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9027
In Commercial Distribution

  • D77810390270 ()
  • D77810390271 ()
103-9027

  • Natural gutta-percha
GUTTA PERCHA POINTS (120/box) Size: 70; For more information: https://www.scottsdental.com/catalog/product/view/id/23534/s/gutta-percha-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9023
In Commercial Distribution

  • D77810390230 ()
  • D77810390231 ()
103-9023

  • Natural gutta-percha
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