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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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NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® MTX is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope. NovoSorb® MTX can be used where a delay in normal wound healing is not considered necessary by the treating physician, e.g., definitive wound closure by secondary intention.
POLYNOVO BIOMATERIALS PTY LIMITED
MTX-0505
In Commercial Distribution

  • 09349155002608 ()
  • 09349155002615 ()
  • 09349155002622 ()

  • Width: 5 Centimeter
  • Length: 5 Centimeter


  • Synthetic wound matrix dressing
NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® MTX is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope. NovoSorb® MTX can be used where a delay in normal wound healing is not considered necessary by the treating physician, e.g., definitive wound closure by secondary intention.
POLYNOVO BIOMATERIALS PTY LIMITED
MTX-2040
In Commercial Distribution

  • 09349155001359 ()
  • 09349155001342 ()
  • 09349155001366 ()

  • Width: 40 Centimeter
  • Length: 20 Centimeter


  • Synthetic wound matrix dressing
NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® MTX is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope. NovoSorb® MTX can be used where a delay in normal wound healing is not considered necessary by the treating physician, e.g., definitive wound closure by secondary intention.
POLYNOVO BIOMATERIALS PTY LIMITED
MTX-1020
In Commercial Distribution

  • 09349155001328 ()
  • 09349155001311 ()
  • 09349155001335 ()

  • Length: 20 Centimeter
  • Width: 10 Centimeter


  • Synthetic wound matrix dressing
NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® MTX is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope. NovoSorb® MTX can be used where a delay in normal wound healing is not considered necessary by the treating physician, e.g., definitive wound closure by secondary intention.
POLYNOVO BIOMATERIALS PTY LIMITED
MTX-1010
In Commercial Distribution

  • 09349155001298 ()
  • 09349155001281 ()
  • 09349155001304 ()

  • Width: 10 Centimeter
  • Length: 10 Centimeter


  • Synthetic wound matrix dressing
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 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).
POTRERO MEDICAL, INC.
FGS-06-UOT.16FS
Not in Commercial Distribution

  • 00868475000297 ()

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

  • 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 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).
POTRERO MEDICAL, INC.
FGS-06-UOT.SMCS
Not in Commercial Distribution

  • 00868475000280 ()
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 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).
POTRERO MEDICAL, INC.
FGS-06-IAP.16FS
Not in Commercial Distribution

  • 00868475000273 ()

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

  • Multi-parameter urinary monitoring system catheter set
IV ADMIN SET, W/ GVS EASYDROP® FLOW REGULATOR,, 0.22µ IN LINE GVS SPEEDFLOW® AIR-ELIMINATING FILTER, DEHP-FREE, 1 Y-SITE, 15µ FILTER IN DRIP CHAMBER, SWIVEL LL, 92"
INTEGRATED MEDICAL SYSTEMS, INC.
IMS044G
In Commercial Distribution

  • 20868564000058 ()
  • 00868564000054 ()


  • Basic intravenous administration set, noninvasive
IV ADMIN SET, W/ GVS EASYDROP® FLOW REGULATOR,, 0.22µ IN LINE GVS SPEEDFLOW® AIR-ELIMINATING FILTER, DEHP-FREE, 1 Y-SITE, 15µ FILTER IN DRIP CHAMBER, SWIVEL LL, 92"
INTEGRATED MEDICAL SYSTEMS, INC.
IMS044G
In Commercial Distribution

  • 10868564000051 ()
  • 00868564000054 ()


  • Basic intravenous administration set, noninvasive
The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine.
BM KOREA CO., LTD
BMK(T)15αS
In Commercial Distribution

  • 08809255544633 ()
  • 08809255542639 ()


  • Catheter/overtube balloon inflator, single-use
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