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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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Bio-Eye® - 00854066006052

Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0018C
In Commercial Distribution

  • 00854066006052 ()

  • Outer Diameter: 18 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant wrap, non-biological
  • Orbital sphere implant

Bio-Eye® - 00854066006120

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations, eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0024P
In Commercial Distribution

  • 00854066006120 ()

  • Outer Diameter: 24 Millimeter


  • Orbital sphere implant
  • Orbital sphere implant wrap, non-biological
  • Ophthalmic conformer

Bio-Eye® - 00854066006113

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0022P
In Commercial Distribution

  • 00854066006113 ()

  • Outer Diameter: 22 Millimeter


  • Orbital sphere implant
  • Orbital sphere implant wrap, non-biological
  • Ophthalmic conformer

Bio-Eye® - 00854066006106

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0020P
In Commercial Distribution

  • 00854066006106 ()

  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant wrap, non-biological
  • Orbital sphere implant
  • Ophthalmic conformer

Bio-Eye® - 00854066006090

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0018P
In Commercial Distribution

  • 00854066006090 ()

  • Outer Diameter: 18 Millimeter


  • Orbital sphere implant wrap, non-biological
  • Orbital sphere implant
  • Ophthalmic conformer

Bio-Eye® - 00854066006083

Perforated Coated Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I0016P
In Commercial Distribution

  • 00854066006083 ()

  • Outer Diameter: 16 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant wrap, non-biological
  • Orbital sphere implant

Optimus Drill Q – 4.0mm 55mm - 09348215109424

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-102
In Commercial Distribution

  • 09348215109424 ()


  • Fluted surgical drill bit, reusable

Optimus Drill Q – 4.0mm 50mm - 09348215109417

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-101
In Commercial Distribution

  • 09348215109417 ()


  • Fluted surgical drill bit, reusable

Optimus Drill Q – 4.0mm 45mm - 09348215109400

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-100
In Commercial Distribution

  • 09348215109400 ()


  • Fluted surgical drill bit, reusable

Optimus Drill Q – 4.0mm 35mm - 09348215109394

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-099
In Commercial Distribution

  • 09348215109394 ()


  • Fluted surgical drill bit, reusable
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