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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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Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of medication for regional anesthesia and pain management in lower extremity blocks. It may be used by a qualified healthcare professional in a perioperative monitored care setting. Certa Catheter™ is intended for use in adult patients only. It should always be inserted and placed under ultrasound guidance by a healthcare professional. The Certa Catheter has not been evaluated for use in upper extremity blocks.
FERROSAN MEDICAL DEVICES SP Z O O
R50C1
Not in Commercial Distribution

  • 05902194190312 ()
  • 05902194190299 ()
  • 05902194190305 ()


  • Peripheral anaesthesia catheter set, non-medicated
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.
FIDIA FARMACEUTICI SPA
FID185704
Not in Commercial Distribution

  • M71389122049663SAM1 ()
  • M71389122049663SAM0 ()

  • Total Volume: 3 Milliliter
FID185704

  • Synovial fluid supplementation medium
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.
FIDIA FARMACEUTICI SPA
89122-0496-63
Not in Commercial Distribution

  • M71389122049663A16 ()
  • M71389122049663 ()

  • Total Volume: 3 Milliliter
89122-0496-63

  • Synovial fluid supplementation medium
The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley) - IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn SmartFoley is a single use device intended for short-term use (less than 30 days).
POTRERO MEDICAL, INC.
FGS-06-UOT.SMCS
In Commercial Distribution

  • 10850019755173 ()
  • 00850019755176 ()
FGS-06-UOT.SMCS

  • Multi-parameter urinary monitoring system connection set
The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley) - IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn SmartFoley is a single use device intended for short-term use (less than 30 days).
POTRERO MEDICAL, INC.
FGS-06-CUOT.16FST
In Commercial Distribution

  • 10850019755159 ()
  • 00850019755152 ()

  • Catheter Gauge: 16 French
FGS-06-CUOT.16FST

  • Multi-parameter urinary monitoring system catheter set
The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley) - IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn SmartFoley is a single use device intended for short-term use (less than 30 days).
POTRERO MEDICAL, INC.
FGS-06-UOT.16FST
In Commercial Distribution

  • 10850019755142 ()
  • 00850019755145 ()

  • Catheter Gauge: 16 French
FGS-06-UOT.16FST

  • Multi-parameter urinary monitoring system catheter set
The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley) - IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn SmartFoley is a single use device intended for short-term use (less than 30 days).
POTRERO MEDICAL, INC.
FGS-06-IAP.16FST
In Commercial Distribution

  • 10850019755128 ()
  • 00850019755121 ()

  • Catheter Gauge: 16 French
FGS-06-IAP.16FST

  • Multi-parameter urinary monitoring system catheter set
The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley) – IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days).
POTRERO MEDICAL, INC.
FGS-06-IAP.14FST
In Commercial Distribution

  • 10850019755111 ()
  • 00850019755114 ()

  • Catheter Gauge: 14 French
FGS-06-IAP.14FST

  • Multi-parameter urinary monitoring system catheter set
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 Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System with the Accuryn Sensing Urinary Catheter (SmartFoley) – IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short term use (less than 30 days).
POTRERO MEDICAL, INC.
FGS-06-IAP.12FST
In Commercial Distribution

  • 10850019755104 ()
  • 00850019755107 ()

  • Catheter Gauge: 12 French
FGS-06-IAP.12FST

  • Multi-parameter urinary monitoring system catheter set
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