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
OXOID LIMITED
DD0005T
In Commercial Distribution

  • 05032384034109 ()


  • X/V factor differentiation disc IVD
XV Factor, HardyDisks™, Hemin and NAD disk to aid in the identification of Haemophilus spp., 50 disks per cartridge, 1 each Contains NAD and Hemin (X and V Factors) for the speciation of Haemophilus.
HARDY DIAGNOSTICS
Z7051
In Commercial Distribution

  • 00816576028351 ()
  • 00816576028368 ()
Z7051

  • X/V factor differentiation disc IVD
HemosIL FII & FV DNA Control
INSTRUMENTATION LABORATORY COMPANY
00020003500
Not in Commercial Distribution

  • 08426950453086 ()
  • 18426950453083 ()
00020003500

  • Inherited thrombophilia IVD, control
eSensor® Thrombophilia Risk Test Reagent Test Pack (TRT) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test Reagent Test (TRT)
Not in Commercial Distribution

  • 00857167005238 ()
MT004008

  • Multiple thrombophilia marker IVD, kit, clotting
eSensor® Thrombophilia Risk Test Amplification Reagents (TRT) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test (TRT)
Not in Commercial Distribution

  • 00857167005221 ()
MT004008

  • Multiple thrombophilia marker IVD, kit, clotting
eSensor® Thrombophilia Risk Test Detection Reagents (TRT) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test (TRT)
Not in Commercial Distribution

  • 00857167005214 ()
MT004008

  • Multiple thrombophilia marker IVD, kit, clotting
eSensor® Thrombophilia Risk Test (TRT) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test (TRT)
Not in Commercial Distribution

  • 00857167005207 ()
MT004013

  • Multiple thrombophilia marker IVD, kit, clotting
eSensor® Thrombophilia Risk Test Cartridge Pouch (TRT) (8)
GENMARK DIAGNOSTICS, INC.
eSensor® Thrombophilia Risk Test (TRT)
Not in Commercial Distribution

  • 00857167005191 ()
KT021053

  • Multiple thrombophilia marker IVD, kit, clotting
Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
AUTOGENOMICS, INC
01-3050-01
Not in Commercial Distribution

  • 00850009370129 ()
01-3050-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
AUTOGENOMICS, INC
01-2050-01
Not in Commercial Distribution

  • 00850009370112 ()
01-2050-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Genotyping system for the detection of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A mutations
AUTOGENOMICS, INC
01-1050-01
Not in Commercial Distribution

  • 00850009370105 ()
01-1050-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Genotyping systme for the detection of the Factor V Leiden G1691A mutation
AUTOGENOMICS, INC
01-3030-01
Not in Commercial Distribution

  • 00850009370099 ()
01-3030-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Genotyping system for the detection of the Factor V Leiden G1691A mutation
AUTOGENOMICS, INC
01-2030-01
Not in Commercial Distribution

  • 00850009370082 ()
01-2030-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Genotyping system for the detection of the Factor V Leiden G1691A mutation
AUTOGENOMICS, INC
01-1030-01
Not in Commercial Distribution

  • 00850009370075 ()
01-1030-01

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
No Description
Roche Diagnostics GmbH
1
In Commercial Distribution

  • 04038377021607 ()
04618777001

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
INVADER FACTOR V, 1680 TESTS
Not in Commercial Distribution

  • 15420045506701 ()
95-457

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
INVADER FACTOR V, 144 TESTS
Not in Commercial Distribution

  • 15420045506664 ()
95-453

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Xpert HemosIL FII & FV kit; 10 test kit
CEPHEID
GXHEMOSIL-10
In Commercial Distribution

  • 07332940000936 ()
GXHEMOSIL-10

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
Xpert Factor II & Factor V kit; 10 test kit
CEPHEID
GXFIIFV-10
In Commercial Distribution

  • 07332940000240 ()
GXFIIFV-10

  • Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)
No Description
Zimmer, Inc.
00-8832-023-36
In Commercial Distribution

  • 00889024153998 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Size V V
00-8832-023-36

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8832-023-32
In Commercial Distribution

  • 00889024153981 ()

  • Size V V
  • Lumen/Inner Diameter: 32 Millimeter
00-8832-023-32

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8831-023-40
In Commercial Distribution

  • 00889024153523 ()

  • Size V V
  • Lumen/Inner Diameter: 40 Millimeter
00-8831-023-40

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8831-023-36
In Commercial Distribution

  • 00889024153516 ()

  • Size V V
  • Lumen/Inner Diameter: 36 Millimeter
00-8831-023-36

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8791-080-00
In Commercial Distribution

  • 00889024152700 ()

  • Size V V
  • Outer Diameter: 80 Millimeter
00-8791-080-00

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8791-078-00
In Commercial Distribution

  • 00889024152694 ()

  • Size V V
  • Outer Diameter: 78 Millimeter
00-8791-078-00

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8758-023-36
In Commercial Distribution

  • 00889024152076 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Size V V
00-8758-023-36

  • Constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8758-023-32
In Commercial Distribution

  • 00889024152069 ()

  • Size V V
  • Lumen/Inner Diameter: 32 Millimeter
00-8758-023-32

  • Constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8757-080-02
In Commercial Distribution

  • 00889024151802 ()

  • Size V V
  • Outer Diameter: 80 Millimeter
00-8757-080-02

  • Acetabular shell
No Description
Zimmer, Inc.
00-8757-080-01
In Commercial Distribution

  • 00889024151796 ()

  • Size V V
  • Outer Diameter: 80 Millimeter
00-8757-080-01

  • Acetabular shell
No Description
Zimmer, Inc.
00-8757-080-00
In Commercial Distribution

  • 00889024151789 ()

  • Outer Diameter: 80 Millimeter
  • Size V V
00-8757-080-00

  • Acetabular shell
No Description
Zimmer, Inc.
00-8757-078-02
In Commercial Distribution

  • 00889024151772 ()

  • Size V V
  • Outer Diameter: 78 Millimeter
00-8757-078-02

  • Acetabular shell
No Description
Zimmer, Inc.
00-8757-078-01
In Commercial Distribution

  • 00889024151765 ()

  • Outer Diameter: 78 Millimeter
  • Size V V
00-8757-078-01

  • Acetabular shell
No Description
Zimmer, Inc.
00-8757-078-00
In Commercial Distribution

  • 00889024151758 ()

  • Size V V
  • Outer Diameter: 78 Millimeter
00-8757-078-00

  • Acetabular shell
No Description
Zimmer, Inc.
00-8755-023-36
In Commercial Distribution

  • 00889024151178 ()

  • Size V V
  • Lumen/Inner Diameter: 36 Millimeter
00-8755-023-36

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8755-023-32
In Commercial Distribution

  • 00889024151161 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • Size V V
00-8755-023-32

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8754-023-36
In Commercial Distribution

  • 00889024150829 ()

  • Size V V
  • Lumen/Inner Diameter: 36 Millimeter
00-8754-023-36

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8754-023-32
In Commercial Distribution

  • 00889024150812 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • Size V V
00-8754-023-32

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8752-023-36
In Commercial Distribution

  • 00889024150065 ()

  • Size V V
  • Lumen/Inner Diameter: 36 Millimeter
00-8752-023-36

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8752-023-32
In Commercial Distribution

  • 00889024150058 ()

  • Size V V
  • Lumen/Inner Diameter: 32 Millimeter
00-8752-023-32

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8751-023-40
In Commercial Distribution

  • 00889024149595 ()

  • Lumen/Inner Diameter: 40 Millimeter
  • Size V V
00-8751-023-40

  • Non-constrained polyethylene acetabular liner
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