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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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APT 9 - 00887661563811

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

  • 00887661563811 ()


  • Tinted non-prescription spectacles

APT 9 - 00887661615305

No Description
FGX INTERNATIONAL INC.
10244270.KHL
In Commercial Distribution

  • 00887661615305 ()


  • Tinted non-prescription spectacles

ProVia 9 - 00763000569839

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

ProVia 9 - 00763000569822

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

ProVia 9 - 00763000569815

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

ProVia 9 - 00763000569808

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

External Fixator Connection 9 / 9 - 07640136270101

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

Cardiovascular Procedure Kit - 00699753525689

No Description
Terumo Cardiovascular Systems Corporation
CX-SA041X
In Commercial Distribution

  • 50699753525684 ()
  • 00699753525689 ()


  • Cardiopulmonary bypass system blood tubing set

FemTrak Femoral Venous Cannula - 00690103180138

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

FemTrak Femoral Venous Cannula - 00690103180121

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 - 00690103168365

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 - 00690103168358

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 - 00690103168341

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

Edwards Lifesciences Femoral Venous Cannula - 00690103146684

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

Edwards Lifesciences Femoral Venous Cannula - 00690103146677

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

Edwards Lifesciences Femoral Venous Cannula - 00690103146660

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

Edwards Lifesciences Femoral Venous Cannula - 00690103146653

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

Edwards Lifesciences Femoral Venous Cannula - 00690103146646

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 - 00690103031287

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 - 00690103031256

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 - 00690103031232

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 - 00690103031218

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 - 00690103031195

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 - 00690103031171

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

TandemHeart - 00814112020111

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

AIMSCREEN MULTIDRUG 9 - 00695684409258

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" Peel-A-Way Introducer - 05707480111596

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 - 00850019007787

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

9'' ABDOMINAL BINDER - 00609271042087

Extra-large Economy
DARCO INTERNATIONAL, INC.
202-0050-55
In Commercial Distribution

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

  • Abdominal binder, reusable

9'' ABDOMINAL BINDER - 00609271042063

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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