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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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Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial 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. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
FIDIA FARMACEUTICI SPA
89122-0724-12
In Commercial Distribution

89122-0724-12

  • 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
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
Bone Screw 2.3mm x 16mm, 5 Pack
TMJ Solutions, Inc.
65-2316
In Commercial Distribution

  • B0046523161 ()
  • B0046123161 ()


  • Total temporomandibular joint prosthesis
Bone Screw 2.3mm x 14mm, 5 Pack
TMJ Solutions, Inc.
65-2314
In Commercial Distribution

  • B0046523141 ()
  • B0046123141 ()


  • Total temporomandibular joint prosthesis
Bone Screw 2.3mm x 12mm, 5 Pack
TMJ Solutions, Inc.
65-2312
In Commercial Distribution

  • B0046523121 ()
  • B0046123121 ()


  • Total temporomandibular joint prosthesis
Bone Screw 2.3mm x 10mm, 5 Pack
TMJ Solutions, Inc.
65-2310
In Commercial Distribution

  • B0046523101 ()
  • B0046123101 ()


  • Total temporomandibular joint prosthesis
Bone Screw 2.3mm x 8mm, 5 Pack
TMJ Solutions, Inc.
65-2308
In Commercial Distribution

  • B0046523081 ()
  • B0046123081 ()


  • Total temporomandibular joint prosthesis
Bone Screw 2.3mm x 6mm, 5 Pack
TMJ Solutions, Inc.
65-2306
In Commercial Distribution

  • B0046523061 ()
  • B0046123061 ()


  • Total temporomandibular joint prosthesis
Bone Screw 2.0mm x 16mm, 5 Pack
TMJ Solutions, Inc.
65-2016
In Commercial Distribution

  • B0046520161 ()
  • B0046120161 ()


  • Total temporomandibular joint prosthesis
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