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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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ACCURUN 1 Series 2700 Multi-Marker Positive Control 3 x 1 mL
Lgc Clinical Diagnostics, Inc.
2000-0006
In Commercial Distribution

  • 00816784020888 ()
2000-0006

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 2700 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0005
In Commercial Distribution

  • 00816784020871 ()
2000-0005

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 8100 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0022
In Commercial Distribution

  • 00816784020789 ()
2000-0022

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 5100 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0017
In Commercial Distribution

  • 00816784020772 ()

  • Total Volume: 42 Milliliter
2000-0017

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 5100 Multi-Marker Positive Control 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0016
In Commercial Distribution

  • 00816784020765 ()

  • Total Volume: 15 Milliliter
2000-0016

  • Multiple blood-borne virus antigen/antibody IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0079
In Commercial Distribution

  • 00816784020741 ()


  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 24 Multi-Marker Confirmatory Control 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0032
In Commercial Distribution

  • 00816784020123 ()
2000-0032

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 5600 Multi-Marker Positive Control 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0018
In Commercial Distribution

  • 00816784020062 ()
2000-0018

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 4400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0010
In Commercial Distribution

  • 00816784020055 ()
2000-0010

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 4000 Multi-Marker 3 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0008
In Commercial Distribution

  • 00816784020048 ()
2000-0008

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 2500 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0002
In Commercial Distribution

  • 00816784020031 ()
2000-0002

  • Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 1 Series 2400 Multi-Marker 12 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0001
In Commercial Distribution

  • 00816784020024 ()
2000-0001

  • Multiple blood-borne virus antigen/antibody IVD, control
No Description
FUJIREBIO INC.
235584
In Commercial Distribution

  • 04987270235584 ()

  • Number of bottles per kit = 8
  • Total mLs per bottle = 3/3/2.5


  • Multiple blood-borne virus antigen/antibody IVD, control
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
20 tests/kit
In Commercial Distribution

  • 06974849369236 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
1 test/kit
In Commercial Distribution

  • 06974849369229 ()


  • Clostridium difficile antigen IVD, kit, rapid ICT, clinical
No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable
Type B 800ml
Well Lead Medical Co.,Ltd
O02A020810
In Commercial Distribution

  • 16936881133777 ()
  • 06936881133770 ()
  • 26936881133774 ()


  • Surgical tissue/fluid collection bag
Type B 550ml
Well Lead Medical Co.,Ltd
O02A020510
In Commercial Distribution

  • 16936881133760 ()
  • 06936881133763 ()
  • 26936881133767 ()


  • Surgical tissue/fluid collection bag
CRANIOTOMY B PACK
Cardinal Health 200, LLC
SNE11CBL10
In Commercial Distribution

  • 50195594238054 ()
  • 10195594238056 ()
SNE11CBL10

  • Craniotomy kit
PAIN TRAY B
Cardinal Health 200, LLC
34A3181A
In Commercial Distribution

  • 50195594249067 ()
  • 10195594249069 ()
34A3181A

  • Peripheral anaesthesia single-administration set, medicated
O B PACK
Cardinal Health 200, LLC
SMA34DLWM1
In Commercial Distribution

  • 50195594009227 ()
  • 10195594009229 ()
SMA34DLWM1

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
O B PACK
MEDLINE INDUSTRIES, INC.
DYNJ85322A
In Commercial Distribution

  • 40195327660667 ()
  • 10195327660666 ()
DYNJ85322A

  • General surgical procedure kit, non-medicated, single-use
OPEN HEART B
MEDLINE INDUSTRIES, INC.
DYNJ903739K
In Commercial Distribution

  • 10195327677527 ()
DYNJ903739K

  • General surgical procedure kit, non-medicated, single-use
HEART B PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ53589G
In Commercial Distribution

  • 10195327697006 ()
DYNJ53589G

  • General surgical procedure kit, non-medicated, single-use
LAVH PART B
MEDLINE INDUSTRIES, INC.
DYNJV0312D
In Commercial Distribution

  • 40195327695447 ()
  • 10195327695446 ()
DYNJV0312D

  • General surgical procedure kit, non-medicated, single-use
CRANIOTOMY B PACK
Cardinal Health 200, LLC
SNE11CBLD9
In Commercial Distribution

  • 50195594079916 ()
  • 10195594079918 ()
SNE11CBLD9

  • Craniotomy kit
O B PACK
Cardinal Health 200, LLC
SMA11OSCTN
In Commercial Distribution

  • 50195594079565 ()
  • 10195594079567 ()
SMA11OSCTN

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
O B PACK
Cardinal Health 200, LLC
SMA34DLWML
In Commercial Distribution

  • 50195594038067 ()
  • 10195594038069 ()
SMA34DLWML

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
STERLIZATION POUCH B
BGSS Company Inc.
STP-7002-B
In Commercial Distribution

  • 00854014003065 ()
  • 00854014003058 ()
  • 00854014003041 ()


  • Sterilization packaging, single-use
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