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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

  • M71389122072412A1 ()
89122-0724-12

  • Synovial fluid supplementation medium
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
Central Compression Screw is a large Independent compression screw used in the Titan™ Reverse Shoulder System used in the centralized compression of baseplate into glenoid
Ascension Orthopedics, Inc.
SCW096005520
In Commercial Distribution

  • 10381780121787 ()
  • M269SCW0960055201 ()

  • 58 mm L x 4.5 mm dia
SCW-0960-055-20

  • Orthopaedic bone screw, non-bioabsorbable, sterile
2 - 1.10mm x 0.50cm VISICOIL separated by a 15mm PGLA spacer (Stranded with PGLA Sleeve) loaded in an 17 gauge pre-waxed brachytherapy needle 20cm in length.
Izi Medical Products, LLC
TLS-110-31517
In Commercial Distribution

  • EIBATLS110315170 ()
TLS-110-31517

  • Radiological image marker, implantable
2 - 0.75mm x 0.50cm VISICOIL separated by a 15mm PGLA Spacer (Stranded with PGLA Sleeve) loaded in an 18 gauge pre-waxed brachytherapy needle 20cm in length.
Izi Medical Products, LLC
TLS-075-31518
In Commercial Distribution

  • EIBATLS075315180 ()
TLS-075-31518

  • Radiological image marker, implantable
2 - 0.75mm x 0.50cm VISICOIL MR separated by 20mm PGLA spacer (Stranded with PGLA Sleeve) loaded in an 18 gauge pre-waxed brachytherapy needle 20cm in length.
Izi Medical Products, LLC
MRTLS-075-92018
In Commercial Distribution

  • EIBAMRTLS075920180 ()
MRTLS-075-92018

  • Radiological image marker, implantable
3M™ Tegaderm™ Transparent Film Dressing Frame Style, 1630, Oval, 4 in x 4-1/2 in (10 cm x 11.5 cm), 50/ct 4ct/Case
3M Deutschland GmbH
1630
In Commercial Distribution

  • 04064035170172 ()
  • 04064035170165 ()
  • 04064035170158 ()
1630

  • Synthetic polymer semi-permeable film dressing, adhesive
3M™ Tegaderm™ HP Transparent Film Dressing Frame Style, 9546HP, 4 in x 4-1/2 in (10 cm x 11.5 cm), 50/ct 4ct/Case
3M Deutschland GmbH
9546HP
In Commercial Distribution

  • 04064035170059 ()
  • 04064035170042 ()
  • 04064035170035 ()
9546HP

  • Synthetic polymer semi-permeable film dressing, adhesive
3M™ Tegaderm™ HP Transparent Film Dressing Frame Style, 9536HP, 4 in x 4-3/4 in (10 cm x 12 cm), 50/ct 4ct/Case
3M Deutschland GmbH
9536HP
In Commercial Distribution

  • 04064035170011 ()
  • 04064035170004 ()
  • 04064035169992 ()
9536HP

  • Synthetic polymer semi-permeable film dressing, adhesive
3M™ Tegaderm™ Silicone Foam Border Dressing, 90642, 6 in x 6 in (15 cm x 15 cm), 10/PAC, 4 PAC/CS, 40/CS
3M Deutschland GmbH
90642
In Commercial Distribution

  • 04064035103897 ()
  • 04064035103880 ()
  • 04064035103873 ()
90642

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
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