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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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Porous Hydroxyapatite Orbital Implant, Sphere, 14mm
CERAMISYS LTD
SP14
Not in Commercial Distribution

  • 05060171621867 ()


  • Orbital sphere implant
Safety Glasses
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-007
In Commercial Distribution

  • 00859626006053 ()
ML-830-01-007

  • Radiation shielding goggles
Orbital implant
FCI S A S FCI 20 22
S6.6014
In Commercial Distribution

  • 13700773728890 ()


  • Orbital sphere implant
Orbital implant
FCI S A S FCI 20 22
S6.6012
In Commercial Distribution

  • 13700773728852 ()


  • Orbital sphere implant
Orbital implant
FCI S A S FCI 20 22
S6.6016
In Commercial Distribution

  • 13700773728081 ()


  • Orbital sphere implant
Orbital implant
FCI S A S FCI 20 22
S6.6022
In Commercial Distribution

  • 13700773724410 ()


  • Orbital sphere implant
Orbital implant
FCI S A S FCI 20 22
S6.6020
In Commercial Distribution

  • 13700773724403 ()


  • Orbital sphere implant
Orbital implant
FCI S A S FCI 20 22
S6.6018
In Commercial Distribution

  • 13700773724397 ()


  • Orbital sphere implant
No Description
KATENA PRODUCTS, INC.
K 8-6220
In Commercial Distribution

  • 00841668112021 ()

  • Outer Diameter: 22 Millimeter
K 8-6220

  • Orbital sphere implant
No Description
KATENA PRODUCTS, INC.
K 8-6200
In Commercial Distribution

  • 00841668112014 ()

  • Outer Diameter: 20 Millimeter
K 8-6200

  • Orbital sphere implant
No Description
KATENA PRODUCTS, INC.
K 8-6180
In Commercial Distribution

  • 00841668112007 ()

  • Outer Diameter: 18 Millimeter
K 8-6180

  • Orbital sphere implant
No Description
KATENA PRODUCTS, INC.
K 8-6160
In Commercial Distribution

  • 00841668111994 ()

  • Outer Diameter: 16 Millimeter
K 8-6160

  • Orbital sphere implant
No Description
KATENA PRODUCTS, INC.
K 8-6140
In Commercial Distribution

  • 00841668111987 ()

  • Outer Diameter: 14 Millimeter
K 8-6140

  • Orbital sphere implant
No Description
KATENA PRODUCTS, INC.
K 8-6120
In Commercial Distribution

  • 00841668111970 ()

  • Outer Diameter: 12 Millimeter
K 8-6120

  • Orbital sphere implant
No Description
KATENA PRODUCTS, INC.
K 8-6100
In Commercial Distribution

  • 00841668111963 ()

  • Outer Diameter: 10 Millimeter
K 8-6100

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14356
Not in Commercial Distribution

  • B091143560 ()

  • Outer Diameter: 22 Millimeter
14356

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14355
Not in Commercial Distribution

  • B091143550 ()

  • Outer Diameter: 20 Millimeter
14355

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14354
Not in Commercial Distribution

  • B091143540 ()

  • Outer Diameter: 18 Millimeter
14354

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14353
Not in Commercial Distribution

  • B091143530 ()

  • Outer Diameter: 16 Millimeter
14353

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14352
Not in Commercial Distribution

  • B091143520 ()

  • Outer Diameter: 14 Millimeter
14352

  • Orbital sphere implant
Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14351
Not in Commercial Distribution

  • B091143510 ()

  • Outer Diameter: 12 Millimeter
14351

  • Orbital sphere implant
No Description
Gulden Ophthalmics Inc.
14256
In Commercial Distribution

  • B091142560 ()

  • Outer Diameter: 22 Millimeter
14256

  • Orbital sphere implant
No Description
Gulden Ophthalmics Inc.
14255
In Commercial Distribution

  • B091142550 ()

  • Outer Diameter: 20 Millimeter
14255

  • Orbital sphere implant
No Description
Gulden Ophthalmics Inc.
14254
In Commercial Distribution

  • B091142540 ()

  • Outer Diameter: 18 Millimeter
14254

  • Orbital sphere implant
No Description
Gulden Ophthalmics Inc.
14253
In Commercial Distribution

  • B091142530 ()

  • Outer Diameter: 16 Millimeter
14253

  • Orbital sphere implant
No Description
Gulden Ophthalmics Inc.
14252
In Commercial Distribution

  • B091142520 ()

  • Outer Diameter: 14 Millimeter
14252

  • Orbital sphere implant
No Description
Gulden Ophthalmics Inc.
14251
In Commercial Distribution

  • B091142510 ()

  • Outer Diameter: 12 Millimeter
14251

  • Orbital sphere implant
No Description
Gulden Ophthalmics Inc.
14250
In Commercial Distribution

  • B091142500 ()

  • Outer Diameter: 10 Millimeter
14250

  • Orbital sphere implant
Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14156
In Commercial Distribution

  • B091141561 ()
  • B091141560 ()

  • Outer Diameter: 22 Millimeter
14156

  • Orbital sphere implant
Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14156
In Commercial Distribution

  • B091141560 ()

  • Outer Diameter: 22 Millimeter
14156

  • Orbital sphere implant
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
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
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
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
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
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
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
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
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
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
Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14150
In Commercial Distribution

  • B091141501 ()
  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant
Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14150
In Commercial Distribution

  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant
MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80014
In Commercial Distribution

  • 07613252088585 ()

  • Diameter: 22.0 Millimeter
80014

  • Orbital sphere implant
MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80012
In Commercial Distribution

  • 07613252088578 ()

  • Diameter: 20.0 Millimeter
80012

  • Orbital sphere implant
MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80008
In Commercial Distribution

  • 07613252088561 ()

  • Diameter: 16.0 Millimeter
80008

  • Orbital sphere implant
Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6322
In Commercial Distribution

  • 07613252088424 ()

  • Diameter: 22.0 Millimeter
6322

  • Orbital sphere implant
MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80010
In Commercial Distribution

  • 07613252084044 ()

  • Diameter: 18.0 Millimeter
80010

  • Orbital sphere implant
Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6327
In Commercial Distribution

  • 07613252083405 ()

  • Diameter: 18.0 Millimeter
6327

  • Orbital sphere implant
Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6326
In Commercial Distribution

  • 07613252083399 ()

  • Diameter: 16.0 Millimeter
6326

  • Orbital sphere implant
Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6316
In Commercial Distribution

  • 07613252083382 ()

  • Diameter: 14.0 Millimeter
6316

  • Orbital sphere implant
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