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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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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. The product is packaged in a one syringe pack.
FIDIA FARMACEUTICI SPA
89122-0496-01
In Commercial Distribution

  • M713891220496010 ()

  • Total Volume: 3 Milliliter
89122-0496-01

  • Synovial fluid supplementation medium
No Description
Spectranetics Corporation
500-303
In Commercial Distribution

  • M204500303AA0 ()
  • 00813132020347 ()

  • Outer Diameter: 0.225 Inch
  • Length: 50 Centimeter
500-303

  • Pacing lead extraction kit, single-use
No Description
Spectranetics Corporation
500-302
In Commercial Distribution

  • M204500302AA0 ()
  • 00813132020330 ()

  • Outer Diameter: 0.192 Inch
  • Length: 50 Centimeter
500-302

  • Pacing lead extraction kit, single-use
No Description
Spectranetics Corporation
500-301
In Commercial Distribution

  • M204500301AA0 ()
  • 00813132020323 ()

  • Outer Diameter: 0.164 Inch
  • Length: 50 Centimeter
500-301

  • Pacing lead extraction kit, single-use
No Description
Spectranetics Corporation
500-013
In Commercial Distribution

  • M204500013AA0 ()
  • 00813132020316 ()

  • Outer Diameter: 0.225 Inch
  • Length: 50 Centimeter
500-013

  • Pacing lead extraction kit, single-use
No Description
Spectranetics Corporation
500-001
In Commercial Distribution

  • M204500001AA0 ()
  • 00813132020293 ()

  • Outer Diameter: 0.164 Inch
  • Length: 50 Centimeter
500-001

  • Pacing lead extraction kit, single-use
No Description
Spectranetics Corporation
CVX-300-P
In Commercial Distribution

CVX-300-P

  • Atherectomy excimer laser system
No Description
Spectranetics Corporation
500-012
In Commercial Distribution

  • M204500012AA0 ()
  • 00813132020309 ()

  • Outer Diameter: 0.192 Inch
  • Length: 50 Centimeter
500-012

  • Pacing lead extraction kit, single-use
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
120-009AA
In Commercial Distribution

  • M204120009AA0 ()
  • 00813132020088 ()

  • Outer Diameter: 2.0 Millimeter
120-009

  • Atherectomy laser system beam guide-catheter, coronary
ELCA™ Coronary Laser Atherectomy Catheter
Spectranetics Corporation
120-008AA
In Commercial Distribution

  • M204120008AA0 ()
  • 00813132020071 ()

  • Outer Diameter: 2.0 Millimeter
120-008

  • Atherectomy laser system beam guide-catheter, coronary
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