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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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Orbital sphere implant - 03760087122435

An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
ENUCLEATION EVISCERATION IMPLANT Ø 12 MM
In Commercial Distribution

  • 03760087122435 ()

  • Outer Diameter: 12 Millimeter
S6.1012U

  • Orbital sphere implant

Durette #4, PMMA (20 mm, 3.5 cc) - 10697660000418

The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-420
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 3.5 Milliliter


  • Orbital sphere implant

Durette #1, PMMA (20 mm, 4.0 cc) - 10697660000388

The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-120
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 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

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

Silicone Spheres (18 mm, 3.1 cc) - 10697660000210

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
11-218
Not in Commercial Distribution


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


  • Orbital sphere implant

Silicone Spheres (16 mm, 2.1 cc) - 10697660000197

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
11-216
Not in Commercial Distribution


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


  • 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

Silicone Spheres (12 mm, 0.9 cc) - 10697660000135

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
11-212
Not in Commercial Distribution


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


  • Orbital sphere implant

Ambler Surgical - 00190660036102

Venus eye sphere, 12.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4130E
In Commercial Distribution

  • 00190660036102 ()
4130E

  • Orbital sphere implant

Ambler Surgical - 00190660036089

Silicone eye sphere, 22.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4128E
In Commercial Distribution

  • 00190660036089 ()
4128E

  • Orbital sphere implant

Ambler Surgical - 00190660036072

Silicone eye sphere, 20.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4127E
In Commercial Distribution

  • 00190660036072 ()
4127E

  • Orbital sphere implant

Ambler Surgical - 00190660036065

Silicone eye sphere, 19.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4126E
In Commercial Distribution

  • 00190660036065 ()
4126E

  • Orbital sphere implant

Ambler Surgical - 00190660036058

Silicone eye sphere, 18.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4125E
In Commercial Distribution

  • 00190660036058 ()
4125E

  • Orbital sphere implant

Ambler Surgical - 00190660036041

Silicone eye sphere, 16.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4124E
In Commercial Distribution

  • 00190660036041 ()
4124E

  • Orbital sphere implant

Ambler Surgical - 00190660036034

Silicone eye sphere, 15.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4123E
In Commercial Distribution

  • 00190660036034 ()
4123E

  • Orbital sphere implant

Ambler Surgical - 00190660036027

Silicone eye sphere, 14.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4122E
In Commercial Distribution

  • 00190660036027 ()
4122E

  • Orbital sphere implant

Ambler Surgical - 00190660036157

Venus eye sphere, 22.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4135E
In Commercial Distribution

  • 00190660036157 ()
4135E

  • Orbital sphere implant

Ambler Surgical - 00190660036140

Venus eye sphere, 20.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4134E
In Commercial Distribution

  • 00190660036140 ()
4134E

  • Orbital sphere implant

Ambler Surgical - 00190660036133

Venus eye sphere, 18.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4133E
In Commercial Distribution

  • 00190660036133 ()
4133E

  • Orbital sphere implant

Ambler Surgical - 00190660036126

Venus eye sphere, 16.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4132E
In Commercial Distribution

  • 00190660036126 ()
4132E

  • Orbital sphere implant

Ambler Surgical - 00190660036119

Venus eye sphere, 14.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4131E
In Commercial Distribution

  • 00190660036119 ()
4131E

  • Orbital sphere implant
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