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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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No Description
FGX INTERNATIONAL INC.
DL4451/72.KHL
In Commercial Distribution

  • 00887661563811 ()


  • Tinted non-prescription spectacles
No Description
FGX INTERNATIONAL INC.
10244270.KHL
In Commercial Distribution

  • 00887661615305 ()


  • Tinted non-prescription spectacles
GDWR 9PROV180HS PROVIA 5PK 180 HY ST
MEDTRONIC, INC.
9PROV180HS
In Commercial Distribution

  • 20763000569833 ()
  • 00763000569839 ()

  • Length: 180.0 Centimeter
  • Outer Diameter: 0.014 Inch


  • Cardiac/peripheral vascular guidewire, single-use
GDWR 9PROV180SS PROVIA 5PK 180 SI ST
MEDTRONIC, INC.
9PROV180SS
In Commercial Distribution

  • 20763000569826 ()
  • 00763000569822 ()

  • Length: 180.0 Centimeter
  • Outer Diameter: 0.014 Inch


  • Cardiac/peripheral vascular guidewire, single-use
GDWR 9PROV300HS PROVIA 5PK 300 HY ST
MEDTRONIC, INC.
9PROV300HS
In Commercial Distribution

  • 20763000569819 ()
  • 00763000569815 ()

  • Length: 300.0 Centimeter
  • Outer Diameter: 0.014 Inch


  • Cardiac/peripheral vascular guidewire, single-use
GDWR 9PROV300SS PROVIA 5PK 300 SI ST
MEDTRONIC, INC.
9PROV300SS
In Commercial Distribution

  • 20763000569802 ()
  • 00763000569808 ()

  • Outer Diameter: 0.014 Inch
  • Length: 300.0 Centimeter


  • Cardiac/peripheral vascular guidewire, single-use
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1040
In Commercial Distribution

  • 07640136270101 ()


  • External orthopaedic fixation system, single-use
No Description
Terumo Cardiovascular Systems Corporation
CX-SA041X
In Commercial Distribution

  • 50699753525684 ()
  • 00699753525689 ()


  • Cardiopulmonary bypass system blood tubing set
Femoral Venous Cannula
Edwards Lifesciences LLC
FTV024
In Commercial Distribution

  • 00690103180138 ()

  • 24 Fr. (8.0 mm) x 68 cm (26.8")
FTV024

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
FTV020
In Commercial Distribution

  • 00690103180121 ()

  • 20 Fr. (6.7 mm) x 55 cm (21.6")
FTV020

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII020AS
In Commercial Distribution

  • 00690103168365 ()

  • 20 Fr. (6.7 mm) x 15 cm (6")
FEMII020AS

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII018AS
In Commercial Distribution

  • 00690103168358 ()

  • 18 Fr. (6.0 mm) x 15 cm (6")
FEMII018AS

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII016AS
In Commercial Distribution

  • 00690103168341 ()

  • 16 Fr. (5.3 mm) x 15 cm (6")
FEMII016AS

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM028
In Commercial Distribution

  • 00690103146684 ()

  • 28 Fr. (9.3 mm) x 68 cm (26.8")
VFEM028

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM024
In Commercial Distribution

  • 00690103146677 ()

  • 24 Fr. (8.0 mm) x 68 cm (26.8")
VFEM024

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM022
In Commercial Distribution

  • 00690103146660 ()

  • 22 Fr. (7.3 mm) x 55 cm (21.6")
VFEM022

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM020
In Commercial Distribution

  • 00690103146653 ()

  • 20 Fr. (6.7 mm) x 55 cm (21.6")
VFEM020

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM018
In Commercial Distribution

  • 00690103146646 ()

  • 18 Fr. (6.0 mm) x 55 cm (21.6")
VFEM018

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII020A
In Commercial Distribution

  • 00690103031287 ()

  • 20 Fr. (6.7 mm) x 15 cm (6")
FEMII020A

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII018A
In Commercial Distribution

  • 00690103031256 ()

  • 18 Fr. (6.0 mm) x 15 cm (6")
FEMII018A

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII016A
In Commercial Distribution

  • 00690103031232 ()

  • 16 Fr. (5.3 mm) x 15 cm (6")
FEMII016A

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Venous Cannula
Edwards Lifesciences LLC
FEMII014V
In Commercial Distribution

  • 00690103031218 ()
  • 50690103031213 ()

  • 14 Fr. (4.7 mm) x 11.5 cm (4.5")
FEMII014V

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII014AT
In Commercial Distribution

  • 00690103031195 ()
  • 50690103031190 ()

  • 14 Fr. (4.7 mm) x 6.5 cm (2.6")
FEMII014AT

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII014A
In Commercial Distribution

  • 00690103031171 ()
  • 50690103031176 ()

  • 14 Fr. (4.7 mm) x 6.5 cm (2.6")
FEMII014A

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
15 Fr x 17 cm femoral arterial cannula with 10 Fr introducer
CARDIACASSIST, INC.
5130-1715
In Commercial Distribution

  • 00814112020111 ()
5130-1715

  • Cardiopulmonary bypass cannula, femoral
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Marijuana (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP), Barbiturates (BAR), Benzodiazpines (BZO).
GERMAINE LABORATORIES, INC
40925
In Commercial Distribution

  • 00695684409258 ()
  • 00695684409251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
9" introducer , stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)
Ambu A/S
418000542
In Commercial Distribution

  • 05707480111619 ()
  • 05707480111602 ()
  • 05707480111596 ()

  • Length: 9 Inch


  • Elastomeric infusion pump kit
DrugSmart Cup 9 CLIA-Waived, THC/COC/OPI2K/OXY/AMP/MET/MTD/BZO/BUP, 25tests/kit
CHEMTRON BIOTECH INC
C-60960D
In Commercial Distribution

  • 00850019007787 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Extra-large Economy
DARCO INTERNATIONAL, INC.
202-0050-55
In Commercial Distribution

  • 10609271042084 ()
  • 00609271042087 ()
  • 20609271042081 ()
202-0050-55

  • Abdominal binder, reusable
Medium/Large Economy
DARCO INTERNATIONAL, INC.
202-0050-45
In Commercial Distribution

  • 20609271042067 ()
  • 00609271042063 ()
  • 10609271042060 ()
202-0050-45

  • Abdominal binder, reusable
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