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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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The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System. Cordella PA Sensor The Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex. Delivery System The Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.
Endotronix, Inc.
100303-05
In Commercial Distribution

  • 00850008997006 ()


  • Implantable pulmonary artery pressure monitoring system
ORTHOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. ORTHOVISC is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
SAIMA GLOBAL FARMA S.L.
277500
In Commercial Distribution

  • 08437027710025 ()


  • Synovial fluid supplementation medium
MONOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. MONOVISC is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
SAIMA GLOBAL FARMA S.L.
277515
In Commercial Distribution

  • 08437027710018 ()


  • Synovial fluid supplementation medium
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles.
FIDIA FARMACEUTICI SPA
89122-0724-20
In Commercial Distribution

  • M713891220724200 ()
89122-0724-20

  • Synovial fluid supplementation medium
The 4170-3 is the Base Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-3
In Commercial Distribution

  • M706417031 ()
4170-3

  • Skin photodynamic therapy/phototherapy lamp
The 4170-2 is the Post Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-2
In Commercial Distribution

  • M706417021 ()
4170-2

  • Skin photodynamic therapy/phototherapy lamp
The 4170-1 is the Head Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-1
In Commercial Distribution

  • M706417011 ()
4170-1

  • Skin photodynamic therapy/phototherapy lamp
The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This Fiber Free model is suitable for sutureless implant techniques or can be sutured. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.
HumanOptics AG
95002
In Commercial Distribution

  • 04049154000029 ()

  • Outer Diameter: 12.8 Millimeter
00095002

  • Implantable iris prosthesis
Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
NK-M3R(U)
In Commercial Distribution

  • 18855036012850 ()
  • 28855036012857 ()


  • Apheresis system tubing set
Indications for FH: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma. Indications for FSGS: The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
NK-M3R(UL)
In Commercial Distribution

  • 18855036020688 ()
  • 28855036020685 ()


  • Apheresis system tubing set
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