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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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
NAVICROSS Support Catheter
TERUMO CORPORATION
NC18151
In Commercial Distribution

  • 54987892077314 ()
  • 04987892077319 ()

  • Max Guide wire O.D. 0.018” (0.46 mm)
  • Length: 150 Centimeter
  • Outer Diameter: 0.85 Millimeter
PN*NA18153H

  • Vascular guide-catheter, single-use
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 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 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
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 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
NAVICROSS Support Catheter
TERUMO CORPORATION
NC18150
In Commercial Distribution

  • 54987892077291 ()
  • 04987892077296 ()

  • Outer Diameter: 0.85 Millimeter
  • Length: 150 Centimeter
  • Max Guide wire O.D. 0.018” (0.46 mm)
PN*NS18153H

  • Vascular guide-catheter, single-use
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 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 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
9/9 OA HATCHET DE
HU-FRIEDY MFG. CO., LLC
CP1239
In Commercial Distribution

  • 10889950043339 ()
CP1239

  • Dental excavator, reusable
SHOWERGUARD 9' X 9' 5PK
CENTURION MEDICAL PRODUCTS CORPORATION
SG9X9
In Commercial Distribution

  • 20653160290190 ()
  • 00653160290196 ()
SG9X9

  • Cast/bandage waterproof bathing cover, single-use
9" x 9" Sterilization Wrap
KIMBERLY-CLARK GLOBAL SALES, LLC
10709
In Commercial Distribution

  • 00036000107098 ()
  • 90036000107091 ()
  • 10036000107095 ()


  • Sterilization packaging, single-use
Spacer 12x15, 9 deg, -9
Zavation LLC
170-0909
In Commercial Distribution

  • 00842166111653 ()


  • Polymeric spinal interbody fusion cage
Spacer 15x17.5, 9 deg, -9
Zavation LLC
171-0909
In Commercial Distribution

  • 00842166112148 ()


  • Polymeric spinal interbody fusion cage
No Description
W.H. Holden, Inc.
10-7209HO
In Commercial Distribution

  • D928107209HO0 ()


  • Scalpel handle, reusable
No Description
W.H. Holden, Inc.
10-7209
In Commercial Distribution

  • D9281072090 ()


  • Scalpel handle, reusable
Conformity stem, #9
UNITED ORTHOPEDIC CORP.
1110-3009
In Commercial Distribution

  • 04711605583268 ()
1110-3009

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular
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
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
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
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
No Description
SURGENTEC, LLC
SR16-5001
In Commercial Distribution

  • 00850040139587 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Titanium Hemostatic Clip - Large Size
PETERS SURGICAL
O9120
In Commercial Distribution

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

  • large
O9120

  • Ligation clip, metallic
Titanium Hemostatic Clip - Small/Medium Size
PETERS SURGICAL
L9180
In Commercial Distribution

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

  • small-medium
L9180

  • Ligation clip, metallic
Titanium Hemostatic Clip - Small Size
PETERS SURGICAL
J9324
In Commercial Distribution

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

  • small
J9324

  • Ligation clip, metallic
Titanium Hemostatic Clip - Small Size
PETERS SURGICAL
J9180
In Commercial Distribution

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

  • small
J9180

  • Ligation clip, metallic
Titanium Hemostatic Clip - Medium Size
PETERS SURGICAL
B9324
In Commercial Distribution

  • 03661624006594 ()
  • 13661522039431 ()
  • 03661522039434 ()

  • medium
B9324

  • Ligation clip, metallic
Titanium Hemostatic Clip - Medium Size
PETERS SURGICAL
B9180
In Commercial Distribution

  • 03661624004774 ()
  • 13661522039424 ()
  • 03661522039427 ()

  • medium
B9180

  • Ligation clip, metallic
Titanium Hemostatic Clip - Micro Size
PETERS SURGICAL
W9060
In Commercial Distribution

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

  • Micro
W9060

  • Ligation clip, metallic
Titanium Hemostatic Clip - Medium/Large Size
PETERS SURGICAL
V9120
In Commercial Distribution

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

  • medium-large
V9120

  • Ligation clip, metallic
Titanium Hemostatic Clip - Small Size
PETERS SURGICAL
R9324
In Commercial Distribution

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

  • small
R9324

  • Ligation clip, metallic
Titanium Hemostatic Clip - Small Size
PETERS SURGICAL
R9180
In Commercial Distribution

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

  • small
R9180

  • Ligation clip, metallic
ContrIL 9 Multipak
INSTRUMENTATION LABORATORY COMPANY
00024001418
In Commercial Distribution

  • 08426950087878 ()
00024001418

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
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