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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

ZZ BASE NB-A-WMSM-L15 WP (White Metal Scanmarker L15 with Screw) - D800ZBED2434L15

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED2434L15
In Commercial Distribution

  • D800ZBED2434L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable

ZZ BASE NB-A-WMSM-L12 WP (White Metal Scanmarker L12 with Screw) - D800ZBED2434L12

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED2434L12
In Commercial Distribution

  • D800ZBED2434L12 ()


  • Dental implant suprastructure, temporary, preformed, reusable

ZZ BASE NB-A-WMSM-L15 CC 3.0 (White Metal Scanmarker L15 with Screw) - D800ZBED2433L15

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED2433L15
In Commercial Distribution

  • D800ZBED2433L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable

ZZ BASE NB-A-WMSM-L12 CC 3.0 (White Metal Scanmarker L12 with Screw) - D800ZBED2433L12

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED2433L12
In Commercial Distribution

  • D800ZBED2433L12 ()


  • Dental implant suprastructure, temporary, preformed, reusable

ZZ BASE NB-A-WMSM-L15 RP (White Metal Scanmarker L15 with Screw) - D800ZBED2432L15

Compatible with Nobel Biocare NobelActive _ NobelReplace CC _ Nobel Parallel CC implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L15 1x White Metal Scanmarker Screw
ZIRKONZAHN SRL
ZBED2432L15
In Commercial Distribution

  • D800ZBED2432L15 ()


  • Dental implant suprastructure, temporary, preformed, reusable
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