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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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Ambler Surgical - 00190660036096

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

Ambler Surgical - 00190660036089

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

Ambler Surgical - 00190660036072

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

Ambler Surgical - 00190660036065

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

Ambler Surgical - 00190660036058

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

Ambler Surgical - 00190660036041

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

Ambler Surgical - 00190660036034

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

Ambler Surgical - 00190660036027

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

Ambler Surgical - 00190660036010

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

Orbital sphere implant - 03760087123104

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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