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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 (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

Cannula-Curette with 60 cc Handyvak Syringe - 00888937000931

Stainless Steel Curette 3mm OD
Coopersurgical, Inc.
MX623
In Commercial Distribution

  • 20888937000935 ()
  • 00888937000931 ()

  • Outer Diameter: 3 Millimeter


  • Endometrial biopsy kit

Resp-O2 Disposable Suction Liner, 3000 cc - 00840117321601

No Description
Dynarex Corporation
32262
In Commercial Distribution

  • 00840117321601 ()
  • 00840117321540 ()


  • Suction system canister liner

Resp-O2 Disposable Suction Liner, 1000 cc - 00840117321588

No Description
Dynarex Corporation
32260
In Commercial Distribution

  • 00840117321588 ()
  • 00840117321526 ()


  • Suction system canister liner

Resp-O2 Disposable Suction Liner, 1500 cc - 00840117321595

No Description
Dynarex Corporation
32261
In Commercial Distribution

  • 00840117321595 ()
  • 00840117321533 ()


  • Suction system canister liner

Acrylic Spheres 22 mm, 5.7 cc - M8721132203

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
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