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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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)
SpO2 interface cable/安维生-Philips/3.0M/087
Unimed Medical Supplies, Inc.
U710-169
In Commercial Distribution

  • 06945664824972 ()


  • Electrical-only medical device connection cable, reusable
SpO2 interface cable/安维生-Nellcor/3.0M/103X
Unimed Medical Supplies, Inc.
U710-170
In Commercial Distribution

  • 06945664824958 ()


  • Electrical-only medical device connection cable, reusable
Reusable SpO2 Sensor/莱康宁/Finger clip/Adult/3.0M/LP5
Unimed Medical Supplies, Inc.
701-000038-001
In Commercial Distribution

  • 06945664821551 ()


  • Pulse oximeter probe, reusable
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
No Description
Zimmer, Inc.
00-8751-023-36
In Commercial Distribution

  • 00889024149588 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Size V V
00-8751-023-36

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8751-023-32
In Commercial Distribution

  • 00889024149571 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • Size V V
00-8751-023-32

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8738-023-36
In Commercial Distribution

  • 00889024149045 ()

  • Size V V
  • Lumen/Inner Diameter: 36 Millimeter
00-8738-023-36

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8738-023-32
In Commercial Distribution

  • 00889024149038 ()

  • Size V V
  • Lumen/Inner Diameter: 32 Millimeter
00-8738-023-32

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8735-023-36
In Commercial Distribution

  • 00889024148772 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Size V V
00-8735-023-36

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8735-023-32
In Commercial Distribution

  • 00889024148765 ()

  • Size V V
  • Lumen/Inner Diameter: 32 Millimeter
00-8735-023-32

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8732-023-36
In Commercial Distribution

  • 00889024147942 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Size V V
00-8732-023-36

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8732-023-32
In Commercial Distribution

  • 00889024147935 ()

  • Size V V
  • Lumen/Inner Diameter: 32 Millimeter
00-8732-023-32

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8731-023-40
In Commercial Distribution

  • 00889024147478 ()

  • Lumen/Inner Diameter: 40 Millimeter
  • Size V V
00-8731-023-40

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8731-023-36
In Commercial Distribution

  • 00889024147461 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Size V V
00-8731-023-36

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8731-023-32
In Commercial Distribution

  • 00889024147454 ()

  • Size V V
  • Lumen/Inner Diameter: 32 Millimeter
00-8731-023-32

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8852-023-36
In Commercial Distribution

  • 00889024155862 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Size V V
00-8852-023-36

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8852-023-32
In Commercial Distribution

  • 00889024155855 ()

  • Size V V
  • Lumen/Inner Diameter: 32 Millimeter
00-8852-023-32

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8851-023-40
In Commercial Distribution

  • 00889024155435 ()

  • Size V V
  • Lumen/Inner Diameter: 40 Millimeter
00-8851-023-40

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8851-023-36
In Commercial Distribution

  • 00889024155428 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Size V V
00-8851-023-36

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8851-023-32
In Commercial Distribution

  • 00889024155411 ()

  • Size V V
  • Lumen/Inner Diameter: 32 Millimeter
00-8851-023-32

  • Non-constrained polyethylene acetabular liner
No Description
Zimmer, Inc.
00-8838-023-36
In Commercial Distribution

  • 00889024154889 ()

  • Size V V
  • Lumen/Inner Diameter: 36 Millimeter
00-8838-023-36

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8838-023-32
In Commercial Distribution

  • 00889024154872 ()

  • Lumen/Inner Diameter: 32 Millimeter
  • Size V V
00-8838-023-32

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8835-023-36
In Commercial Distribution

  • 00889024154612 ()

  • Lumen/Inner Diameter: 36 Millimeter
  • Size V V
00-8835-023-36

  • Acetabulum prosthesis trial, prefabricated, reusable
No Description
Zimmer, Inc.
00-8835-023-32
In Commercial Distribution

  • 00889024154605 ()

  • Size V V
  • Lumen/Inner Diameter: 32 Millimeter
00-8835-023-32

  • 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.
00-8832-023-36
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
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