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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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No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-2010-22
Not in Commercial Distribution

  • 04049016072461 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-2005-22
In Commercial Distribution

  • 04049016040354 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-1010-22
In Commercial Distribution

  • 04049016040347 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-1005-22
In Commercial Distribution

  • 04049016040330 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FA 1201-1003-22
Not in Commercial Distribution

  • 04049016040323 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
No Description
Joline GmbH & Co. KG
US7NA2120
In Commercial Distribution

  • 04250203940580 ()


  • Balloon kyphoplasty kit
No Description
Joline GmbH & Co. KG
US7HA2120
In Commercial Distribution

  • 04250203940566 ()


  • Balloon kyphoplasty kit
No Description
Joline GmbH & Co. KG
US7OA2120
In Commercial Distribution

  • 04250203940542 ()


  • Balloon kyphoplasty kit
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
In Commercial Distribution


  • Length: 28 Millimeter
  • Width: 23 Nanometer
  • Depth: 1.8 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
19-092
In Commercial Distribution


  • Length: 25.5 Millimeter
  • Width: 21 Millimeter
  • Depth: 1.8 Millimeter


  • Ophthalmic conformer
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