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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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SUPARTZ FX sodium hyaluronate - M717715644440

SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-4444-1
In Commercial Distribution

  • M717715644440 ()
  • M717715644442 ()
  • M717715644443 ()
  • M717715644444 ()
7156-4444

  • Synovial fluid supplementation medium

TriPhasix™ - M595S4000

1lb. TriPhasix™ Chromatic Alginate
PARKELL, INC.
S400
Not in Commercial Distribution

  • M595S4043 ()
  • M595S4000 ()
  • M595S4022 ()
  • M595S4011 ()
S400

  • Silicone dental impression material

Axiom® Lig-A-Boots® - M6653010

Instrument Jaw Covers, Multi-Color Pack
AXIOM MEDICAL, INCORPORATED
301
In Commercial Distribution

  • M6653013 ()
  • M6653011 ()
  • M6653010 ()
  • M6653015 ()


  • Vascular booties

Axiom® Lig-A-Boots® - M6653000

Instrument Jaw Covers, White
AXIOM MEDICAL, INCORPORATED
300
In Commercial Distribution

  • M6653003 ()
  • M6653001 ()
  • M6653000 ()
  • M6653005 ()


  • Vascular booties

Axiom® Lig-A-Loops® - M6651180

Retraction Tape, Mini, Blue, Veins
AXIOM MEDICAL, INCORPORATED
118
In Commercial Distribution

  • M6651185 ()
  • M6651183 ()
  • M6651181 ()
  • M6651180 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651170

Retraction Tape, Mini, White, Nerves
AXIOM MEDICAL, INCORPORATED
117
In Commercial Distribution

  • M6651175 ()
  • M6651173 ()
  • M6651171 ()
  • M6651170 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651160

Retraction Tape, Mini, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
116
In Commercial Distribution

  • M6651165 ()
  • M6651163 ()
  • M6651161 ()
  • M6651160 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651150

Retraction Tape, Mini, Red, Arteries
AXIOM MEDICAL, INCORPORATED
115
In Commercial Distribution

  • M6651155 ()
  • M6651153 ()
  • M6651151 ()
  • M6651150 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651140

Retraction Tape, Maxi, Blue, Veins
AXIOM MEDICAL, INCORPORATED
114
In Commercial Distribution

  • M6651145 ()
  • M6651143 ()
  • M6651141 ()
  • M6651140 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651130

Retraction Tape, Maxi, White, Nerves
AXIOM MEDICAL, INCORPORATED
113
In Commercial Distribution

  • M6651135 ()
  • M6651133 ()
  • M6651131 ()
  • M6651130 ()


  • Surgical support tape, non-bioabsorbable
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