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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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3.5 x 14 mm R3CON Locking Plate Screw
Paragon 28, Inc.
P50-353-3514
In Commercial Distribution

  • 00889795016478 ()

  • Outer Diameter: 3.5 Millimeter
  • 3.5 x 14 mm R3CON Locking Plate Screw
P50-353-3514

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.5 x 12 mm R3CON Locking Plate Screw
Paragon 28, Inc.
P50-353-3512
In Commercial Distribution

  • 00889795016461 ()

  • 3.5 x 12 mm R3CON Locking Plate Screw
  • Outer Diameter: 3.5 Millimeter
P50-353-3512

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.5 x 10 mm R3CON Locking Plate Screw
Paragon 28, Inc.
P50-353-3510
In Commercial Distribution

  • 00889795016454 ()

  • 3.5 x 10 mm R3CON Locking Plate Screw
  • Outer Diameter: 3.5 Millimeter
P50-353-3510

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Pilon Fusion, Backpack Drill Guide
Paragon 28, Inc.
P51-926-5004
In Commercial Distribution

  • 00889795150028 ()
P51-926-5004

  • Surgical drill guide, reusable
Pilon Fusion Depth Gage
Paragon 28, Inc.
P51-926-8001
In Commercial Distribution

  • 00889795146632 ()
P51-926-8001

  • Surgical depth gauge, reusable
Pilon Fusion, Tray Lid
Paragon 28, Inc.
P50-900-PFTL
In Commercial Distribution

  • 00889795146526 ()
P50-900-PFTL

  • Device sterilization/disinfection container, reusable
Pilon Fusion, Proximal Driver
Paragon 28, Inc.
P51-926-1005
In Commercial Distribution

  • 00889795146519 ()
P51-926-1005

  • Surgical screwdriver, reusable
Pilon Fusion, Backpack Guide, Left
Paragon 28, Inc.
P51-926-5003
In Commercial Distribution

  • 00889795146441 ()
P51-926-5003

  • Surgical drill guide, reusable
Pilon Fusion, Caddy Lid
Paragon 28, Inc.
P50-900-PFCL
In Commercial Distribution

  • 00889795146434 ()
P50-900-PFCL

  • Device sterilization/disinfection container, reusable
Pilon Fusion, Tray Base
Paragon 28, Inc.
P50-900-PFIC
In Commercial Distribution

  • 00889795146427 ()
P50-900-PFIC

  • Device sterilization/disinfection container, reusable
Pilon Fusion, Caddy Base, Plates
Paragon 28, Inc.
P50-900-PFPC
In Commercial Distribution

  • 00889795146410 ()
P50-900-PFPC

  • Device sterilization/disinfection container, reusable
Pilon Fusion, Reciprocating Rasp
Paragon 28, Inc.
P51-926-7001
In Commercial Distribution

  • 00889795146175 ()
P51-926-7001

  • Bone file/rasp, manual, reusable
Pilon Fusion, Plate Handle
Paragon 28, Inc.
P51-926-6001
In Commercial Distribution

  • 00889795146168 ()
P51-926-6001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Pilon Fusion, Attachment Rod
Paragon 28, Inc.
P51-926-5002
In Commercial Distribution

  • 00889795146151 ()
P51-926-5002

  • Device control handling knob
Pilon Fusion, Backpack Guide, Right
Paragon 28, Inc.
P51-926-5001
In Commercial Distribution

  • 00889795146144 ()
P51-926-5001

  • Surgical drill guide, reusable
Pilon Fusion, King Cobra Cartilage Removal Tool
Paragon 28, Inc.
P51-926-4001
In Commercial Distribution

  • 00889795146137 ()
P51-926-4001

  • Cartilage knife
Pilon Fusion, K-Wire Guide, Monster
Paragon 28, Inc.
P51-926-2002
In Commercial Distribution

  • 00889795146120 ()
P51-926-2002

  • Surgical drill guide, reusable
Pilon Fusion, Drill Guide, Monster
Paragon 28, Inc.
P51-926-2001
In Commercial Distribution

  • 00889795146113 ()
P51-926-2001

  • Surgical drill guide, reusable
Pilon Fusion, Proximal Drill Guide
Paragon 28, Inc.
P51-926-1003
In Commercial Distribution

  • 00889795146090 ()
P51-926-1003

  • Surgical drill guide, reusable
Pilon Fusion, Trocar
Paragon 28, Inc.
P51-926-1001
In Commercial Distribution

  • 00889795146076 ()
P51-926-1001

  • Orthopaedic implantation sleeve, reusable
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
Aesku.Diagnostics GmbH & Co. KG
51.181.US.BULK5
In Commercial Distribution

  • 04250289513562 ()
51.181.US.BULK5

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
Aesku.Diagnostics GmbH & Co. KG
51.181.US
In Commercial Distribution

  • 04250289513487 ()
51.181.US

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.050.US
In Commercial Distribution

  • 04250289510370 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.100.US
In Commercial Distribution

  • 04250289510356 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES ANA HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA HEp-2 Test System is intended for use as aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.
Aesku.Diagnostics GmbH & Co. KG
51.100.US
In Commercial Distribution

  • 04250289504461 ()
51.100.US

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum.
Aesku.Diagnostics GmbH & Co. KG
53.120.US
In Commercial Distribution

  • 04250289513401 ()
53.120.US

  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum. This in vitro diagnostic assay is used as an aid for the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. The assay can be processed manually and analyzed at the microscope or processed and analyzed with HELIOS® Automated IFA System. All suggested results obtained with the HELIOS® Automated IFA System must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
53.100.US
In Commercial Distribution

  • 04250289510394 ()


  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.051.US
Not in Commercial Distribution

  • 04250289510387 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.
Aesku.Diagnostics GmbH & Co. KG
54.101.US
In Commercial Distribution

  • 04250289510363 ()


  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum by manual microscopy or with the HELIOS® Automated IFA System. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.
Aesku.Diagnostics GmbH & Co. KG
51.101.US.Bulk5
In Commercial Distribution

  • 04250289504942 ()
51.101.US.Bulk5

  • Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
Kerasave is a low salt, vitamin, amino acid, and glucose-enriched iso-osmolar corneal culture balanced medium with sodium pyruvate as an ATP precursor and dextran as a deturgescent agent. It is supplemented with 100 ug/ml gentamicin sulfate and 200 ug/ml streptomycin sulfate, and a tablet to be dissolved in the medium prior to use, corresponding to 2.5 ug/ml of amphotericin B. It has sodium bicarbonate and Hepes buffers to maintain pH in the range of 7.2 – 7.6 and Phenol red as a pH indicator. It provides basic nutrients for cell maintenance.
AL.CHI.MI.A. SRL
KER 001-00
In Commercial Distribution

  • 08021118001408 ()
  • 18021118001405 ()

  • Total Volume: 20 Milliliter


  • Corneal storage medium
No Description
BIOGENEX LABORATORIES
AM392-10M
In Commercial Distribution

  • 00810119677303 ()

  • Total Volume: 10 Milliliter
AM392-10M

  • Homeobox protein CDX-2 IVD, antibody
No Description
BIOGENEX LABORATORIES
AM236-10M
In Commercial Distribution

  • 00810119677280 ()

  • Total Volume: 10 Milliliter
AM236-10M

  • CD34 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM322-10M
In Commercial Distribution

  • 00810119677273 ()

  • Total Volume: 10 Milliliter
AM322-10M

  • CD3 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AX246-YCD
In Commercial Distribution

  • 00810119677266 ()
AX246-YCD

  • Cytokeratin IVD, antibody
No Description
BIOGENEX LABORATORIES
AM302-10M
In Commercial Distribution

  • 00810119676726 ()

  • Total Volume: 10 Milliliter
AM302-10M

  • CD15 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AX363-YCD
In Commercial Distribution

  • 00810119676689 ()
AX363-YCD

  • Synaptophysin IVD, antibody
No Description
BIOGENEX LABORATORIES
AX414-YCD
In Commercial Distribution

  • 00810119676665 ()
AX414-YCD

  • CD79a cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AX126-YCD
In Commercial Distribution

  • 00810119676610 ()
AX126-YCD

  • Chromogranin A IVD, antibody
No Description
BIOGENEX LABORATORIES
AX232-YCD
In Commercial Distribution

  • 00810119676603 ()
AX232-YCD

  • CD31 endothelial cell marker IVD, antibody
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