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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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M4 Cement Mixer for Manifold with HV Bone Cement
STRYKER CORPORATION
0707002000
In Commercial Distribution

  • 07613327545258 ()
0707-002-000

  • Orthopaedic cement preparation/delivery kit
A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.
NOVOSCI CORP.
SHC02
In Commercial Distribution

  • B066SHC023 ()
  • B066SHC020 ()
SHC02

  • Cardiopulmonary bypass system blood tubing set
A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.
NOVOSCI CORP.
SFC02
In Commercial Distribution

  • B066SFC023 ()
  • B066SFC020 ()
SFC02

  • Cardiopulmonary bypass system blood tubing set
A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.
NOVOSCI CORP.
SFB02
In Commercial Distribution

  • B066SFB023 ()
  • B066SFB020 ()
SFB02

  • Cardiopulmonary bypass system blood tubing set
A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.
NOVOSCI CORP.
SDB02
In Commercial Distribution

  • B066SDB023 ()
  • B066SDB020 ()
SDB02

  • Cardiopulmonary bypass system blood tubing set
A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
NOVOSCI CORP.
301028-000
In Commercial Distribution

  • B0663010280006 ()
  • B0663010280000 ()
  • B0663010280005 ()
  • B0663010280004 ()
  • B0663010280003 ()
301028-000

  • Cardioplegia solution administration adaptor
A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
NOVOSCI CORP.
301022-000
In Commercial Distribution

  • B0663010220006 ()
  • B0663010220000 ()
  • B0663010220005 ()
  • B0663010220004 ()
  • B0663010220003 ()
301022-000

  • Cardioplegia solution administration adaptor
Composite Mesh,Monofilament Polyester with Absorbable Collagen Film, Pre-Placed Sutures and Marking
SOFRADIM PRODUCTION
SYM4024EF
In Commercial Distribution

  • 10884521190597 ()

  • Width: 24 Centimeter
  • Length: 40 Centimeter


  • Extra-gynaecological surgical mesh, composite-polymer
Sterile (14 x 60.9cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophilic pad
CIVCO MEDICAL INSTRUMENTS CO., INC.
H2O-008, H2O-008-5
In Commercial Distribution

  • 00841436114974 ()
  • 10841436114971 ()
  • 00841436114981 ()

  • Width: 24 Inch
  • Length: 5.5 Inch
H2O-008, H2O-008-5

  • Body-surface ultrasound imaging transducer cover
Sterile (14 x 60.9cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophilic ultrasound pad
CIVCO MEDICAL INSTRUMENTS CO., INC.
H2O-003, H2O-003-5
In Commercial Distribution

  • 00841436114882 ()
  • 10841436114889 ()
  • 00841436114899 ()

  • Width: 24 Inch
  • Length: 5.5 Inch
H2O-003, H2O-003-5

  • Body-surface ultrasound imaging transducer cover
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