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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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Orbtex Orbital Implant - 05060171621973

Porous alumina orbital implant with suture platform, sphere, 18mm
CERAMISYS LTD
RPX18
Not in Commercial Distribution

  • 05060171621973 ()


  • Orbital sphere implant

Orbtex Orbital Implant - 05060171621966

Porous alumina orbital implant with suture platform, sphere, 16mm
CERAMISYS LTD
RPX16
Not in Commercial Distribution

  • 05060171621966 ()


  • Orbital sphere implant

Alumina Orbital Implant - 05060171621959

Porous Alumina Orbital Implant, Sphere, 22mm
CERAMISYS LTD
SA22
Not in Commercial Distribution

  • 05060171621959 ()


  • Orbital sphere implant

Alumina Orbital Implant - 05060171621942

Porous Alumina Orbital Implant, Sphere, 20mm
CERAMISYS LTD
SA20
Not in Commercial Distribution

  • 05060171621942 ()


  • Orbital sphere implant

Alumina Orbital Implant - 05060171621935

Porous Alumina Orbital Implant, Sphere, 18mm
CERAMISYS LTD
SA18
Not in Commercial Distribution

  • 05060171621935 ()


  • Orbital sphere implant

Alumina Orbital Implant - 05060171621928

Porous Alumina Orbital Implant, Sphere, 16mm
CERAMISYS LTD
SA16
Not in Commercial Distribution

  • 05060171621928 ()


  • Orbital sphere implant

Alumina Orbital Implant - 05060171621911

Porous Alumina Orbital Implant, Sphere, 14mm
CERAMISYS LTD
SA14
Not in Commercial Distribution

  • 05060171621911 ()


  • Orbital sphere implant

Hydroxyapatite Orbital Implant - 05060171621904

Porous Hydroxyapatite Orbital Implant, Sphere, 22mm
CERAMISYS LTD
SP22
Not in Commercial Distribution

  • 05060171621904 ()


  • Orbital sphere implant

Hydroxyapatite Orbital Implant - 05060171621898

Porous Hydroxyapatite Orbital Implant, Sphere, 20mm
CERAMISYS LTD
SP20
Not in Commercial Distribution

  • 05060171621898 ()


  • Orbital sphere implant

Hydroxyapatite Orbital Implant - 05060171621881

Porous Hydroxyapatite Orbital Implant, Sphere, 18mm
CERAMISYS LTD
SP18
Not in Commercial Distribution

  • 05060171621881 ()


  • Orbital sphere implant

Hydroxyapatite Orbital Implant - 05060171621874

Porous Hydroxyapatite Orbital Implant, Sphere, 16mm
CERAMISYS LTD
SP16
Not in Commercial Distribution

  • 05060171621874 ()


  • Orbital sphere implant

Hydroxyapatite Orbital Implant - 05060171621867

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

  • 05060171621867 ()


  • Orbital sphere implant

ML 830® - 00859626006053

Safety Glasses
MICROLIGHT CORPORATION OF AMERICA
ML-830-01-007
In Commercial Distribution

  • 00859626006053 ()
ML-830-01-007

  • Radiation shielding goggles

EZYPOR® Ø 14 mm - 13700773728890

Orbital implant
FCI S A S FCI 20 22
S6.6014
In Commercial Distribution

  • 13700773728890 ()


  • Orbital sphere implant

EZYPOR® Ø 12 mm - 13700773728852

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

  • 13700773728852 ()


  • Orbital sphere implant

EZYPOR® Ø 16 mm - 13700773728081

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

  • 13700773728081 ()


  • Orbital sphere implant

EZYPOR® Ø 22 mm - 13700773724410

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

  • 13700773724410 ()


  • Orbital sphere implant

EZYPOR® Ø 20 mm - 13700773724403

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

  • 13700773724403 ()


  • Orbital sphere implant

EZYPOR® Ø 18 mm - 13700773724397

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

  • 13700773724397 ()


  • Orbital sphere implant

EYE SPHERE PLASTIC 22MM DIAMETER - 00841668112021

No Description
KATENA PRODUCTS, INC.
K 8-6220
In Commercial Distribution

  • 00841668112021 ()

  • Outer Diameter: 22 Millimeter
K 8-6220

  • Orbital sphere implant

EYE SPHERE PLASTIC 20MM DIAMETER - 00841668112014

No Description
KATENA PRODUCTS, INC.
K 8-6200
In Commercial Distribution

  • 00841668112014 ()

  • Outer Diameter: 20 Millimeter
K 8-6200

  • Orbital sphere implant

EYE SPHERE PLASTIC 18MM DIAMETER - 00841668112007

No Description
KATENA PRODUCTS, INC.
K 8-6180
In Commercial Distribution

  • 00841668112007 ()

  • Outer Diameter: 18 Millimeter
K 8-6180

  • Orbital sphere implant

EYE SPHERE PLASTIC 16MM DIAMETER - 00841668111994

No Description
KATENA PRODUCTS, INC.
K 8-6160
In Commercial Distribution

  • 00841668111994 ()

  • Outer Diameter: 16 Millimeter
K 8-6160

  • Orbital sphere implant

EYE SPHERE PLASTIC 14MM DIAMETER - 00841668111987

No Description
KATENA PRODUCTS, INC.
K 8-6140
In Commercial Distribution

  • 00841668111987 ()

  • Outer Diameter: 14 Millimeter
K 8-6140

  • Orbital sphere implant

EYE SPHERE PLASTIC 12MM DIAMETER - 00841668111970

No Description
KATENA PRODUCTS, INC.
K 8-6120
In Commercial Distribution

  • 00841668111970 ()

  • Outer Diameter: 12 Millimeter
K 8-6120

  • Orbital sphere implant

EYE SPHERE PLASTIC 10MM DIAMETER - 00841668111963

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 - 22mm - B091143560

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 - 20mm - B091143550

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 - 18mm - B091143540

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 - 16mm - B091143530

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 - 14mm - B091143520

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 - 12mm - B091143510

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

22mm Sterile Orbital Implant (PMMA) - B091142560

No Description
Gulden Ophthalmics Inc.
14256
In Commercial Distribution

  • B091142560 ()

  • Outer Diameter: 22 Millimeter
14256

  • Orbital sphere implant

20mm Sterile Orbital Implant (PMMA) - B091142550

No Description
Gulden Ophthalmics Inc.
14255
In Commercial Distribution

  • B091142550 ()

  • Outer Diameter: 20 Millimeter
14255

  • Orbital sphere implant

18mm Sterile Orbital Implant (PMMA) - B091142540

No Description
Gulden Ophthalmics Inc.
14254
In Commercial Distribution

  • B091142540 ()

  • Outer Diameter: 18 Millimeter
14254

  • Orbital sphere implant

16mm Sterile Orbital Implant (PMMA) - B091142530

No Description
Gulden Ophthalmics Inc.
14253
In Commercial Distribution

  • B091142530 ()

  • Outer Diameter: 16 Millimeter
14253

  • Orbital sphere implant

14mm Sterile Orbital Implant (PMMA) - B091142520

No Description
Gulden Ophthalmics Inc.
14252
In Commercial Distribution

  • B091142520 ()

  • Outer Diameter: 14 Millimeter
14252

  • Orbital sphere implant

12mm Sterile Orbital Implant (PMMA) - B091142510

No Description
Gulden Ophthalmics Inc.
14251
In Commercial Distribution

  • B091142510 ()

  • Outer Diameter: 12 Millimeter
14251

  • Orbital sphere implant

10mm Sterile Orbital Implant (PMMA) - B091142500

No Description
Gulden Ophthalmics Inc.
14250
In Commercial Distribution

  • B091142500 ()

  • Outer Diameter: 10 Millimeter
14250

  • Orbital sphere implant

22mm Eye Sphere (non-sterile) - B091141561

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
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