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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
SR12-6011
In Commercial Distribution

  • 00858406007594 ()


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

  • 00858406007587 ()


  • Spinal guidewire
No Description
SURGENTEC, LLC
FC-G-16S
In Commercial Distribution

  • 00858406007570 ()


  • Spinal guidewire
No Description
SURGENTEC, LLC
FC-D-45
In Commercial Distribution

  • 00858406007495 ()


  • Fluted surgical drill bit, reusable
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 (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 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 HemCon Patch PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon Patch PRO controls bleeding caused by extreme trauma. The HemCon Patch PRO offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumanii. Only single strains of most species mentioned have been studied.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 20870053001859 ()
  • 00870053001855 ()
  • 50870053001850 ()
1005

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HemCon GuardaCare PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053001367 ()
  • 20870053001361 ()
  • 50870053001362 ()
1013

  • Chitosan haemostatic agent, professional, non-bioabsorbable
HemCon GuardaCare PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053001350 ()
  • 20870053001354 ()
  • 50870053001355 ()
1012

  • Chitosan haemostatic agent, professional, non-bioabsorbable
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