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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AFFINITY Lumbar Interbody Fusion System, 28mm x 34mm x 6 degrees x 11mm, UNCOATED
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B521106028340611UC0 ()

  • Height: 11 Millimeter
  • Angle: 6 degree
  • Width: 34 Millimeter
  • Length: 28 Millimeter
106-02834-0611-UC

  • Polymeric spinal fusion cage, sterile
AFFINITY Lumbar Interbody Fusion System, 28mm x 34mm x 6 degrees x 10mm, UNCOATED
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B521106028340610UC0 ()

  • Height: 10 Millimeter
  • Angle: 6 degree
  • Width: 34 Millimeter
  • Length: 28 Millimeter
106-02834-0610-UC

  • Polymeric spinal fusion cage, sterile
AFFINITY Lumbar Interbody Fusion System, 28mm x 34mm x 6 degrees x 9mm, UNCOATED
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B521106028340609UC0 ()

  • Height: 9 Millimeter
  • Angle: 6 degree
  • Width: 34 Millimeter
  • Length: 28 Millimeter
106-02834-0609-UC

  • Polymeric spinal fusion cage, sterile
AFFINITY Lumbar Interbody Fusion System, 28mm x 34mm x 6 degrees x 8mm, UNCOATED
AURORA SPINE, INC.
AFFINITY
In Commercial Distribution

  • B521106028340608UC0 ()

  • Height: 8 Millimeter
  • Angle: 6 degree
  • Width: 34 Millimeter
  • Length: 28 Millimeter
106-02834-0608-UC

  • Polymeric spinal fusion cage, sterile
Screw, 3.5mm, Interfragment, 28mm
ARTHROSURFACE INCORPORATED
4F01-4028
In Commercial Distribution

  • M5284F0140280 ()

  • Length: 28 Millimeter
4F01-4028

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-094V
Not in Commercial Distribution

  • M87219094V9 ()

  • Depth: 1.8 Millimeter
  • Width: 23 Millimeter
  • Length: 28 Millimeter


  • Ophthalmic conformer
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-094TV
Not in Commercial Distribution

  • M87219094TV90 ()

  • Depth: 1.8 Millimeter
  • Width: 23 Millimeter
  • Length: 28 Millimeter


  • Ophthalmic conformer
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-094T
Not in Commercial Distribution

  • M87219094T03 ()

  • Depth: 1.8 Millimeter
  • Width: 23 Millimeter
  • Length: 28 Millimeter


  • Ophthalmic conformer
Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-094
Not in Commercial Distribution

  • M872190940 ()

  • Depth: 1.8 Millimeter
  • Width: 23 Nanometer
  • Length: 28 Millimeter


  • Ophthalmic conformer
Bone Screw 2x28 Headed Short Thread Cannulated Ti
GRAMERCY EXTREMITY ORTHOPEDICS LLC
10002028
In Commercial Distribution

  • B471100020280 ()

  • Length: 28 Millimeter
  • Outer Diameter: 2 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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