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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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SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-7006
In Commercial Distribution

  • 00858406007907 ()


  • Spinal bone screw, bioabsorbable
SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-7007
In Commercial Distribution

  • 00858406007884 ()


  • Spinal bone screw, bioabsorbable
SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6006
In Commercial Distribution

  • 00858406007860 ()


  • Spinal bone screw, bioabsorbable
SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6013
In Commercial Distribution

  • 00858406007808 ()


  • Spinal bone screw, bioabsorbable
SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6011
In Commercial Distribution

  • 00858406007594 ()


  • Spinal bone screw, bioabsorbable
No Description
SURGENTEC, LLC
FC-G-16S
In Commercial Distribution

  • 00858406007570 ()


  • Spinal guidewire
The ARK Methotrexate Assay c-Pack is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-02
In Commercial Distribution

  • 00858724003254 ()
5026-0001-02

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
The ARK Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-00
In Commercial Distribution

  • 00858724003056 ()
5026-0001-00

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
The ARK Methotrexate Assay (non c-Pack format) is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers.
ARK DIAGNOSTICS INC
5026-0001-01
In Commercial Distribution

  • 00858724003216 ()
5026-0001-01

  • Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
The Brux-TMD Quicksplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid through bicuspid. It is a two component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch. While it is worn, the Brux-TMD Quicksplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature and opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
TRUER MEDICAL, INC.
90509
In Commercial Distribution

  • 00859290006151 ()
  • 10859290006158 ()
  • 20859290006155 ()
  • 30859290006152 ()
90000FG

  • Mouthguard, reusable
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