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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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Arthrex Calcium Sulfate BioBeads, 20 cc - 00850018568180

BONE VOID FILLER
DIMENSIONAL BIOCERAMICS LLC
ABS-3000-20
In Commercial Distribution

  • 00850018568180 ()

  • Total Volume: 20 Milliliter
ABS-3000-20

  • Bone matrix implant, synthetic, non-antimicrobial

Arthrex Calcium Sulfate BioBeads, 10 cc - 00850018568098

BONE VOID FILLER
DIMENSIONAL BIOCERAMICS LLC
ABS-3000-10
In Commercial Distribution

  • 00850018568098 ()

  • Total Volume: 10 Milliliter
ABS-3000-10

  • Bone matrix implant, synthetic, non-antimicrobial

Arthrex Calcium Sulfate BioBeads, 5 cc - 00850018568081

BONE VOID FILLER
DIMENSIONAL BIOCERAMICS LLC
ABS-3000-05
In Commercial Distribution

  • 00850018568081 ()

  • Total Volume: 5 Milliliter
ABS-3000-05

  • Bone matrix implant, synthetic, non-antimicrobial

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 (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 (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

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
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