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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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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
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
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
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
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
No Description
SURGENTEC, LLC
SR16-5001
In Commercial Distribution

  • 00850040139587 ()


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

  • 00842430105876 ()
  • 00842430109041 ()
1921

  • Freestanding headrest, single-use
DrugSmart Cup 9 CLIA-Waived, AMP/COC/OPI2K/MET/PCP/BAR/BZO/PPX/MTD, 25tests/kit
CHEMTRON BIOTECH INC
C-60930D
In Commercial Distribution

  • 00812203030605 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Wheelchair cushion
Vicair B.V.
OCT9/SPECIAL SIZE
In Commercial Distribution

  • 08717261055763 ()


  • Wheelchair seat cushion
configurable liquid handling workstation
Tecan Schweiz AG
Veya Dx 9
In Commercial Distribution

  • 07640137480295 ()
30246218

  • Pipetting system IVD
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
Portable Suction Device
SSCOR, INC.
2109
Not in Commercial Distribution

  • B24521091 ()


  • Emergency airway clearance suction system, electric
No Description
Sonova AG
9.0 USB Stick
In Commercial Distribution

  • 07613389675313 ()
058-0321

  • Audiometric/hearing device software
ContrIL 9 Multipak
INSTRUMENTATION LABORATORY COMPANY
00024001418
In Commercial Distribution

  • 08426950087878 ()
00024001418

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
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
SALVIN DENTAL SPECIALTIES, LLC
MOLT 9
In Commercial Distribution

  • 00841336102385 ()


  • Dental elevator, tooth/root
Kit Contains: CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CFF03, 5x100 Kii Fios ADVFIX 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CTF33, 11x100 Kii Fios ZTHR 6/BX
APPLIED MEDICAL RESOURCES CORPORATION
GK416
In Commercial Distribution

  • 20607915134116 ()


  • Laparoscopic access cannula, single-use
  • Laparoscopic irrigation/aspiration cannula
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Tissue extraction bag
  • Ligation clip, metallic
No Description
Berman Instruments LLC
DSC16
Not in Commercial Distribution

  • 00810060722565 ()


  • Dental surgical scissors
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, A2, 12 g
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BZ4243212
In Commercial Distribution

  • J017BZ42432120 ()


  • Dental appliance fabrication material, ceramic
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