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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 (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 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 rooster 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 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
89130-5555-01
Not in Commercial Distribution

  • M717715655554 ()
  • M717715655553 ()
  • M717715655552 ()
  • M717715655550 ()
7156-5555

  • Synovial fluid supplementation medium
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
Compatible with: 3.4mm, 4.1mm, 5.0mm, and 6.0mm Platform Internal BIOMET 3i Certain implants Large Diameter ComScrew Titanium, 1.2mm (.048") Hex, 20Ncm
DIAMODENT INC
N/A
In Commercial Distribution

  • D907AJ6512 ()
  • D907AJ6510 ()
  • D907AJ6511 ()
AJ651

  • Dental prosthesis/implant abutment screw
Compatible with: 3.4mm, 4.1mm, 5.0mm, and 6.0mm Platform Internal BIOMET 3i Certain implants Small Diameter ComScrew Titanium, 1.2mm (.048") Hex, 20Ncm
DIAMODENT INC
N/A
In Commercial Distribution

  • D907AJ6502 ()
  • D907AJ6500 ()
  • D907AJ6501 ()
AJ650

  • Dental prosthesis/implant abutment screw
Compatible with: 6.0mm NobelReplace implants UCLA Abutment, Clear Plastic, Green Non-Engaging, 1.0mm Collar, 6.5mm Profile
DIAMODENT INC
N/A
In Commercial Distribution

  • D907AD2012 ()
  • D907AD2010 ()
  • D907AD2011 ()
AD201

  • Dental implant suprastructure, permanent, preformed
Compatible with: 6.0mm NobelReplace implants UCLA Abutment, Clear Plastic, Green Engaging, 1.0mm Collar, 6.5mm Profile
DIAMODENT INC
N/A
In Commercial Distribution

  • D907AD2002 ()
  • D907AD2000 ()
  • D907AD2001 ()
AD200

  • Dental implant suprastructure, permanent, preformed
Compatible with: 5.0mm Wide Platform (WP) NobelReplace implants Overdenture Abutment, Clear Plastic, Blue Non-Engaging
DIAMODENT INC
N/A
In Commercial Distribution

  • D907AC4012 ()
  • D907AC4010 ()
  • D907AC4011 ()
AC401

  • Dental implant suprastructure, permanent, preformed
Compatible with: 5.0mm Wide Platform (WP) NobelReplace implants UCLA Abutment, Clear Plastic, Blue Non-Engaging, 1.0mm Collar, 5.5mm Profile
DIAMODENT INC
N/A
In Commercial Distribution

  • D907AC2012 ()
  • D907AC2010 ()
  • D907AC2011 ()
AC201

  • Dental implant suprastructure, permanent, preformed
Compatible with: 5.0mm Wide Platform (WP) NobelReplace implants UCLA Abutment, Clear Plastic, Blue Engaging, 1.0mm Collar, 5.5mm Profile
DIAMODENT INC
N/A
In Commercial Distribution

  • D907AC2002 ()
  • D907AC2000 ()
  • D907AC2001 ()
AC200

  • Dental implant suprastructure, permanent, preformed
Compatible with: 4.3mm Regular Platform (RP) NobelReplace implants Overdenture Abutment, Clear Plastic, Yellow Non-Engaging
DIAMODENT INC
N/A
In Commercial Distribution

  • D907AB4012 ()
  • D907AB4010 ()
  • D907AB4011 ()
AB401

  • Dental implant suprastructure, permanent, preformed
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