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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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Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-220V
Not in Commercial Distribution

  • M87211220V9 ()

  • Outer Diameter: 20 Millimeter
  • Total Volume: 4.2 Milliliter


  • Orbital sphere implant
Bone Graft Instrument Set - 20° Graft Shaper
LIMACORPORATE SPA
Bone Graft Instrument Set
In Commercial Distribution

  • 08033390118330 ()

  • 20°
9013.75.472

  • Orthopaedic reamer guide
Bone Graft Instrument Set - 20° Graft Shaper
LIMACORPORATE SPA
Bone Graft Instrument Set
In Commercial Distribution

  • 08033390109611 ()

  • 20°
9013.75.476

  • Orthopaedic reamer guide
broach
implantcast GmbH
80049020
In Commercial Distribution

  • 04048844196646 ()

  • 20


  • Orthopaedic broach
SPINAL CURETTE STR 8'' 2-0
SURGIX MEDICAL LLC
G2N87116
In Commercial Distribution

  • 00840343720612 ()

  • Length: 8 Inch
  • 2-0
G2N87116

  • Bone curette, reusable
No Description
Biomet Orthopedics, LLC
909102
In Commercial Distribution

  • 00887868568534 ()

  • 20°
909102

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PRIMA TT Glenoid - Trial Baseplate Full Wedge 20°
LIMACORPORATE SPA
9019.75.920
In Commercial Distribution

  • 08033390241021 ()

  • 20°
9019.75.920

  • Shoulder glenoid fossa prosthesis trial
PRIMA TT Glenoid - K-Wire Positioning Jig Dia. 25 mm 20°
LIMACORPORATE SPA
9019.75.320
In Commercial Distribution

  • 08033390240703 ()

  • 20°
9019.75.320

  • Orthopaedic prosthesis implantation positioning instrument, reusable
CLS Brevius Kinectiv Rasp Size 20
Zimmer GmbH
01.00297.200
In Commercial Distribution

  • 00889024280861 ()

  • 20


  • Bone file/rasp, manual, reusable
No Description
Zimmer, Inc.
SSI005640
In Commercial Distribution

  • 00889024584976 ()

  • 20
SSI005640

  • Femoral stem prosthesis trial
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