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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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NAVICROSS - 04987892077272

NAVICROSS Support Catheter
TERUMO CORPORATION
NC18131
In Commercial Distribution

  • 54987892077277 ()
  • 04987892077272 ()

  • Max Guide wire O.D. 0.018” (0.46 mm)
  • Length: 135 Centimeter
  • Outer Diameter: 0.85 Millimeter
PN*NA180N3H

  • Vascular guide-catheter, single-use

NAVICROSS - 04987892077258

NAVICROSS Support Catheter
TERUMO CORPORATION
NC18130
In Commercial Distribution

  • 54987892077253 ()
  • 04987892077258 ()

  • Length: 135 Centimeter
  • Max Guide wire O.D. 0.018” (0.46 mm)
  • Outer Diameter: 0.85 Millimeter
PN*NS180N3H

  • Vascular guide-catheter, single-use

NAVICROSS - 04987892077234

NAVICROSS Support Catheter
TERUMO CORPORATION
NC18901
In Commercial Distribution

  • 54987892077239 ()
  • 04987892077234 ()

  • Max Guide wire O.D. 0.018” (0.46 mm)
  • Length: 90 Centimeter
  • Outer Diameter: 0.85 Millimeter
PN*NA18093H

  • Vascular guide-catheter, single-use

NAVICROSS - 04987892077210

NAVICROSS Support Catheter
TERUMO CORPORATION
NC18900
In Commercial Distribution

  • 54987892077215 ()
  • 04987892077210 ()

  • Outer Diameter: 0.85 Millimeter
  • Max Guide wire O.D. 0.018” (0.46 mm)
  • Length: 90 Centimeter
PN*NS18093H

  • Vascular guide-catheter, single-use

NAVICROSS - 04987892077197

NAVICROSS Support Catheter
TERUMO CORPORATION
NC18651
In Commercial Distribution

  • 54987892077192 ()
  • 04987892077197 ()

  • Max Guide wire O.D. 0.018” (0.46 mm)
  • Outer Diameter: 0.85 Millimeter
  • Length: 65 Centimeter
PN*NA180G3H

  • Vascular guide-catheter, single-use

NAVICROSS - 04987892077173

NAVICROSS Support Catheter
TERUMO CORPORATION
NC18650
In Commercial Distribution

  • 54987892077178 ()
  • 04987892077173 ()

  • Outer Diameter: 0.85 Millimeter
  • Max Guide wire O.D. 0.018” (0.46 mm)
  • Length: 65 Centimeter
PN*NS180G3H

  • Vascular guide-catheter, single-use

FINECROSS - 04987892058875

FineCross M3 Coronary Micro-Guide Catheter
TERUMO CORPORATION
M3-1430
In Commercial Distribution

  • 54987892058870 ()
  • 04987892058875 ()

  • Length: 130 Centimeter
  • Outer Diameter: 0.61 Millimeter
  • Outer Diameter: 0.84 Millimeter
  • Clinically Relevant Size 1 is relative to catheter distal part. Clinically Relevant Size 2 is relative to catheter proximal part.
NC*A853B

  • Vascular guide-catheter, single-use

FINECROSS - 04987892058851

FineCross M3 Coronary Micro-Guide Catheter
TERUMO CORPORATION
M3-1450
In Commercial Distribution

  • 54987892058856 ()
  • 04987892058851 ()

  • Clinically Relevant Size 1 is relative to catheter distal part. Clinically Relevant Size 2 is relative to catheter proximal part.
  • Outer Diameter: 0.84 Millimeter
  • Outer Diameter: 0.61 Millimeter
  • Length: 150 Centimeter
NC*A855B

  • Vascular guide-catheter, single-use

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

SCALPEL HANDLE #9 - D928107209HO0

No Description
W.H. Holden, Inc.
10-7209HO
In Commercial Distribution

  • D928107209HO0 ()


  • Scalpel handle, reusable

SCALPEL HANDLE #9 - D9281072090

No Description
W.H. Holden, Inc.
10-7209
In Commercial Distribution

  • D9281072090 ()


  • Scalpel handle, reusable

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 - 00609271042063

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

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

  • Abdominal binder, reusable

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

SI Guidewire 9" - 00850040139587

No Description
SURGENTEC, LLC
SR16-5001
In Commercial Distribution

  • 00850040139587 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

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

CLIP 9 VITALITEC - 03661522040164

Titanium Hemostatic Clip - Micro Size
PETERS SURGICAL
W9060
In Commercial Distribution

  • 03661522040164 ()
  • 03661624004651 ()
  • 13661522040161 ()

  • Micro
W9060

  • Ligation clip, metallic

CLIP 9 VITALITEC - 03661522039991

Titanium Hemostatic Clip - Medium/Large Size
PETERS SURGICAL
V9120
In Commercial Distribution

  • 03661624004811 ()
  • 13661522039998 ()
  • 03661522039991 ()

  • medium-large
V9120

  • Ligation clip, metallic

CLIP 9 VITALITEC - 03661522039953

Titanium Hemostatic Clip - Small Size
PETERS SURGICAL
R9324
In Commercial Distribution

  • 03661624006600 ()
  • 13661522039950 ()
  • 03661522039953 ()

  • small
R9324

  • Ligation clip, metallic

CLIP 9 VITALITEC - 03661522039946

Titanium Hemostatic Clip - Small Size
PETERS SURGICAL
R9180
In Commercial Distribution

  • 03661624004712 ()
  • 13661522039943 ()
  • 03661522039946 ()

  • small
R9180

  • Ligation clip, metallic

CLIP 9 VITALITEC - 03661522039533

Titanium Hemostatic Clip - Large Size
PETERS SURGICAL
O9120
In Commercial Distribution

  • 03661624004835 ()
  • 13661522039530 ()
  • 03661522039533 ()

  • large
O9120

  • Ligation clip, metallic

CLIP 9 VITALITEC - 03661522039519

Titanium Hemostatic Clip - Small/Medium Size
PETERS SURGICAL
L9180
In Commercial Distribution

  • 03661624004750 ()
  • 13661522039516 ()
  • 03661522039519 ()

  • small-medium
L9180

  • Ligation clip, metallic

CLIP 9 VITALITEC - 03661522039496

Titanium Hemostatic Clip - Small Size
PETERS SURGICAL
J9324
In Commercial Distribution

  • 03661624006587 ()
  • 13661522039493 ()
  • 03661522039496 ()

  • small
J9324

  • Ligation clip, metallic

CLIP 9 VITALITEC - 03661522039489

Titanium Hemostatic Clip - Small Size
PETERS SURGICAL
J9180
In Commercial Distribution

  • 03661522039489 ()
  • 03661624004675 ()
  • 13661522039486 ()

  • small
J9180

  • Ligation clip, metallic
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