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
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
No Description
SURGENTEC, LLC
SR16-5001
In Commercial Distribution

  • 00850040139587 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
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
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
1921
In Commercial Distribution

  • 00842430105876 ()
  • 00842430109041 ()
1921

  • Freestanding headrest, single-use
Wheelchair cushion
Vicair B.V.
OCT9/SPECIAL SIZE
In Commercial Distribution

  • 08717261055763 ()


  • Wheelchair seat cushion
crea.lign Opaker 9 D3 4 g
bredent GmbH & Co. KG
CLFHOP09
In Commercial Distribution

  • EBRECLFHOP099 ()
  • EBRECLFHOP090 ()
CLFHOP09

  • Dental veneer, professional
No Description
ESAOTE SPA
100644000
In Commercial Distribution

  • 08056304452658 ()


  • General-purpose ultrasound imaging system
No Description
Zimmer, Inc.
SSI007515
In Commercial Distribution

  • 00889024673878 ()

  • TYPE 9
SSI007515

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
SSI007513
In Commercial Distribution

  • 00889024673854 ()
SSI007513

  • Orthopaedic prosthesis implantation positioning instrument, reusable
ContrIL 9 Multipak
INSTRUMENTATION LABORATORY COMPANY
00024001418
In Commercial Distribution

  • 08426950087878 ()
00024001418

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
No Description
SALVIN DENTAL SPECIALTIES, LLC
MOLT 9
In Commercial Distribution

  • 00841336102385 ()


  • Dental elevator, tooth/root
configurable liquid handling workstation
Tecan Schweiz AG
Veya Dx 9
In Commercial Distribution

  • 07640137480295 ()
30246218

  • Pipetting system IVD
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
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
VM 9 DENTINE, A3, 12 g
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BZ4245312
In Commercial Distribution

  • J017BZ42453120 ()


  • Dental appliance fabrication material, ceramic
VM 9 DENTINE, A2, 12 g
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BZ4245212
In Commercial Distribution

  • J017BZ42452120 ()


  • Dental appliance fabrication material, ceramic
VM 9 DENTINE, A1, 12 g
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BZ4245112
In Commercial Distribution

  • J017BZ42451120 ()


  • Dental appliance fabrication material, ceramic
VM 9 OPAQUE DENTINE, A3, 12 g
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BZ4243312
In Commercial Distribution

  • J017BZ42433120 ()


  • Dental appliance fabrication material, ceramic
VM 9 OPAQUE DENTINE, A2, 12 g
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BZ4243212
In Commercial Distribution

  • J017BZ42432120 ()


  • Dental appliance fabrication material, ceramic
VM 9 OPAQUE DENTINE, A1, 12 g
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BZ4243112
In Commercial Distribution

  • J017BZ42431120 ()


  • Dental appliance fabrication material, ceramic
VM 9 OPAQUE DENTINE, 3M2, 12 g
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BZ4207612
In Commercial Distribution

  • J017BZ42076120 ()


  • Dental appliance fabrication material, ceramic
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