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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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
Venus eye sphere, 22.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4135E
In Commercial Distribution

  • 00190660036157 ()
4135E

  • Orbital sphere implant
Venus eye sphere, 20.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4134E
In Commercial Distribution

  • 00190660036140 ()
4134E

  • Orbital sphere implant
Venus eye sphere, 18.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4133E
In Commercial Distribution

  • 00190660036133 ()
4133E

  • Orbital sphere implant
Venus eye sphere, 16.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4132E
In Commercial Distribution

  • 00190660036126 ()
4132E

  • Orbital sphere implant
Venus eye sphere, 14.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4131E
In Commercial Distribution

  • 00190660036119 ()
4131E

  • Orbital sphere implant
Venus eye sphere, 12.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4130E
In Commercial Distribution

  • 00190660036102 ()
4130E

  • Orbital sphere implant
Venus eye sphere, 10.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4129E
In Commercial Distribution

  • 00190660036096 ()
4129E

  • Orbital sphere implant
Silicone eye sphere, 22.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4128E
In Commercial Distribution

  • 00190660036089 ()
4128E

  • Orbital sphere implant
Silicone eye sphere, 20.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4127E
In Commercial Distribution

  • 00190660036072 ()
4127E

  • Orbital sphere implant
Silicone eye sphere, 19.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4126E
In Commercial Distribution

  • 00190660036065 ()
4126E

  • Orbital sphere implant
Silicone eye sphere, 18.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4125E
In Commercial Distribution

  • 00190660036058 ()
4125E

  • Orbital sphere implant
Silicone eye sphere, 16.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4124E
In Commercial Distribution

  • 00190660036041 ()
4124E

  • Orbital sphere implant
Silicone eye sphere, 15.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4123E
In Commercial Distribution

  • 00190660036034 ()
4123E

  • Orbital sphere implant
Silicone eye sphere, 14.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4122E
In Commercial Distribution

  • 00190660036027 ()
4122E

  • Orbital sphere implant
Silicone eye sphere, 12.0mm diameter, packaged individually, non-sterile, disposable, box of 1
AMBLER SURGICAL CORP.
4120E
In Commercial Distribution

  • 00190660036010 ()
4120E

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
EGG SHAPED BIOCERAMIC ORBITAL IMPLANT DIA. 20 MM
In Commercial Distribution

  • 03760087123104 ()

  • Outer Diameter: 20 Millimeter
S6.5340U

  • Orbital sphere implant
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