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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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20mm Eye Sphere (non-sterile) - B091141551

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14155
In Commercial Distribution

  • B091141551 ()
  • B091141550 ()

  • Outer Diameter: 20 Millimeter
14155

  • Orbital sphere implant

20mm Eye Sphere (non-sterile) - B091141550

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14155
In Commercial Distribution

  • B091141550 ()

  • Outer Diameter: 20 Millimeter
14155

  • Orbital sphere implant

18mm Eye Sphere (non-sterile) - B091141541

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14154
In Commercial Distribution

  • B091141541 ()
  • B091141540 ()

  • Outer Diameter: 18 Millimeter
14154

  • Orbital sphere implant

18mm Eye Sphere (non-sterile) - B091141540

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14154
In Commercial Distribution

  • B091141540 ()

  • Outer Diameter: 18 Millimeter
14154

  • Orbital sphere implant

16mm Eye Sphere (non-sterile) - B091141531

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14153
In Commercial Distribution

  • B091141531 ()
  • B091141530 ()

  • Outer Diameter: 16 Millimeter
14153

  • Orbital sphere implant

16mm Eye Sphere (non-sterile) - B091141530

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14153
In Commercial Distribution

  • B091141530 ()

  • Outer Diameter: 16 Millimeter
14153

  • Orbital sphere implant

14mm Eye Sphere (non-sterile) - B091141521

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14152
In Commercial Distribution

  • B091141521 ()
  • B091141520 ()

  • Outer Diameter: 14 Millimeter
14152

  • Orbital sphere implant

14mm Eye Sphere (non-sterile) - B091141520

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14152
In Commercial Distribution

  • B091141520 ()

  • Outer Diameter: 14 Millimeter
14152

  • Orbital sphere implant

12mm Eye Sphere (non-sterile) - B091141511

Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14151
In Commercial Distribution

  • B091141511 ()
  • B091141510 ()

  • Outer Diameter: 12 Millimeter
14151

  • Orbital sphere implant

12mm Eye Sphere (non-sterile) - B091141510

Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14151
In Commercial Distribution

  • B091141510 ()

  • Outer Diameter: 12 Millimeter
14151

  • Orbital sphere implant
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