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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ZEISS NC4 MICRO.NAV.SYS. II SET
Stryker Leibinger GmbH & Co. KG
7700-054-000
In Commercial Distribution

  • 04546540487322 ()
7700-054-000

  • Multi-purpose stereotactic surgery system
LEICA DI MICROSCOPE NAV. SYSTEM II KIT
Stryker Leibinger GmbH & Co. KG
7700-064-000
In Commercial Distribution

  • 04546540487339 ()
7700-064-000

  • Multi-purpose stereotactic surgery system
ZEISS PENTERO MICR. NAV.SYSTEM II KIT
Stryker Leibinger GmbH & Co. KG
7700-074-000
In Commercial Distribution

  • 04546540432445 ()
7700-074-000

  • Multi-purpose stereotactic surgery system
ZEISS NC4 MICROSCOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-055-000
In Commercial Distribution

  • 07613252516941 ()
7700-055-000

  • Multi-purpose stereotactic surgery system
LEICA MICROSCOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-065-000
In Commercial Distribution

  • 07613252516934 ()
7700-065-000

  • Multi-purpose stereotactic surgery system
ZEISS PENTERO MICROSKOPE KIT FOR NAV3I
Stryker Leibinger GmbH & Co. KG
7700-075-000
In Commercial Distribution

  • 07613252516927 ()
7700-075-000

  • Multi-purpose stereotactic surgery system
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
No Description
Roche Diagnostics GmbH
1
In Commercial Distribution

  • 04038377021607 ()
04618777001

  • 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
01-3050-01
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)
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
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)
SDP/PLP PROT MANUL,LN 09081-00
HAEMONETICS CORPORATION
09081-00
In Commercial Distribution

  • 20812747012482 ()
  • 10812747012485 ()


  • Apheresis system
MCS+ SDP/PLP CON FIL,994CF-CPP
HAEMONETICS CORPORATION
994CF-CPP
In Commercial Distribution

  • 10812747012270 ()
  • 30812747012274 ()

  • Total Volume: 1000 Milliliter
  • Total Volume: 225 Milliliter


  • Apheresis system tubing set
1000mm 750mm V-Series (115U) - 1000mm 800mm PLP
Amico Clinical Solutions Corp
LP
In Commercial Distribution

  • 00684706008951 ()
LP-1818-V-PLP-115U

  • Operating room light
1000mm 1000mm V-Series (115U) - 1200mm 1000mm PLP
Amico Clinical Solutions Corp
LP
In Commercial Distribution

  • 00684706008814 ()
LP-1121-V-PLP-115U

  • Operating room light
800mm 800mm Normal Arm - 1000mm 800mm PLP
Amico Clinical Solutions Corp
LP
In Commercial Distribution

  • 00684706008739 ()
LP-8818-N-PLP

  • Operating room light
MCS+ SDP/PLP W/SALINE,LN 994
HAEMONETICS CORPORATION
00994-00
In Commercial Distribution

  • 30812747012090 ()
  • 10812747012096 ()

  • Total Volume: 1000 Milliliter
  • Total Volume: 600 Milliliter
  • Total Volume: 50 Milliliter


  • Apheresis system tubing set
CBL 024,PLP,TWINPIN,5LEAD,YOKE10FT,AHA
CURBELL MEDICAL PRODUCTS, INC.
CBT-05JB-10CS-0121
In Commercial Distribution

  • 00840828125383 ()
5658

  • Electrocardiographic electrode connector
CBL 020,PLP,TWINPIN,3LEAD,YOKE10FT,AHA
CURBELL MEDICAL PRODUCTS, INC.
CBT-03GB-10CS-0021
In Commercial Distribution

  • 00840828125284 ()
5634

  • Electrocardiographic electrode connector
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.
00-8752-023-36
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.
00-8758-023-36
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
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