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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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The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips
TOBY ORTHOPAEDICS
NA
In Commercial Distribution

  • 00816101010257 ()
TO-PHP-L73

  • Orthopaedic fixation plate, non-bioabsorbable
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
11-322
Not in Commercial Distribution

  • M8721132203 ()

  • Total Volume: 5.7 Milliliter
  • Outer Diameter: 22 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
11-320
Not in Commercial Distribution

  • M8721132001 ()

  • Total Volume: 3.6 Milliliter
  • Outer Diameter: 20 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
11-318
Not in Commercial Distribution

  • M8721131808 ()

  • Total Volume: 2.8 Milliliter
  • Outer Diameter: 18 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
11-316
Not in Commercial Distribution

  • M8721131606 ()

  • Total Volume: 2.1 Milliliter
  • Outer Diameter: 16 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
11-314
Not in Commercial Distribution

  • M8721131404 ()

  • Total Volume: 1.5 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
11-312
Not in Commercial Distribution

  • M8721131202 ()

  • Total Volume: 1.1 Milliliter
  • Outer Diameter: 12 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
11-222V
Not in Commercial Distribution

  • M87211222V9 ()

  • Total Volume: 5.6 Milliliter
  • Outer Diameter: 22 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
11-222
Not in Commercial Distribution

  • M8721122202 ()

  • Total Volume: 5.6 Milliliter
  • Outer Diameter: 22 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
11-221V
Not in Commercial Distribution

  • M87211221V9 ()

  • Outer Diameter: 21 Millimeter
  • Total Volume: 4.8 Milliliter


  • Orbital sphere implant
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