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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).
FIDIA FARMACEUTICI SPA
FID185704
Not in Commercial Distribution

  • M71389122496630SAM1 ()
  • M71389122496630SAM0 ()

  • 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).
FIDIA FARMACEUTICI SPA
89122-4966-30
Not in Commercial Distribution

  • M71389122496630A16 ()
  • M71389122496630A ()

  • Total Volume: 3 Milliliter
89122-4966-30

  • Synovial fluid supplementation medium
BioCera Fibers QDS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing BioCera Fibers QDS results in a cotton-like physical form. Due to its physical form, BioCera Fibers QDS is flexible and can easily fill defects in appropriate amounts.
ORTHOREBIRTH CO.,LTD.
0.25g
In Commercial Distribution

  • 04573190050552 ()

  • Total Volume: 2 Milliliter
ORB-0305D-KC

  • Synthetic bone graft
CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology. The pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk for BSE. The device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a solution of propylene glycol and sealed in a container impermeable to air and moisture.
ADMEDUS REGEN PTY LTD
UC0307A90
In Commercial Distribution

  • 09348992000327 ()

  • Width: 3 Centimeter
  • Length: 7 Centimeter
  • Angle: 90 degree
C0307A90

  • Cardiovascular patch, animal-derived
Angiographic Catheter, JL 4.5, 6F
Oscor Inc.
ANG1-0270
In Commercial Distribution

  • 50885672103601 ()
  • 00885672103606 ()

  • Length: 100 Centimeter
  • Flow Rate: 38 mL/sec
  • Recommended Pressure Limit: 1200 psi max.
  • Maximum Recommended Guidewire 0.038 in
ANG1-0270

  • Angiographic catheter, single-use
Angiographic Catheter, JR 3.5, 6F
Oscor Inc.
ANG1-0052
In Commercial Distribution

  • 50885672103595 ()
  • 00885672103590 ()

  • Flow Rate: 39 mL/sec
  • Length: 100 Centimeter
  • Recommended Pressure Limit: 1200 psi max.
  • Maximum Recommended Guidewire 0.038 in
ANG1-0052

  • Angiographic catheter, single-use
Angiographic Catheter, JL 3.5, 6F
Oscor Inc.
ANG1-0252
In Commercial Distribution

  • 50885672103588 ()
  • 00885672103583 ()

  • Flow Rate: 39 mL/sec
  • Recommended Pressure Limit: 1200 psi max.
  • Length: 100 Centimeter
  • Maximum Recommended Guidewire 0.038 in
ANG1-0252

  • Angiographic catheter, single-use
Angiographic Catheter, Internal Mammary, 6F
Oscor Inc.
ANG106-0205
In Commercial Distribution

  • 50885672102994 ()
  • 00885672102999 ()

  • Recommended Pressure Limit: 1200 psi max.
  • Length: 100 Centimeter
  • Flow Rate: 36 mL/sec
  • Maximum Recommended Guidewire 0.038 in
ANG106-0205

  • Angiographic catheter, single-use
Angiographic Catheter, Amplatz Left II, 6F
Oscor Inc.
ANG106-0111
In Commercial Distribution

  • 50885672102987 ()
  • 00885672102982 ()

  • Length: 100 Centimeter
  • Maximum Recommended Guidewire 0.038 in
  • Recommended Pressure Limit: 1200 psi max.
  • Flow Rate: 35 mL/sec
ANG106-0111

  • Angiographic catheter, single-use
Angiographic Catheter, Amplatz Left I, 6F
Oscor Inc.
ANG106-0105
In Commercial Distribution

  • 50885672102970 ()
  • 00885672102975 ()

  • Recommended Pressure Limit: 1200 psi max.
  • Maximum Recommended Guidewire 0.038 in
  • Flow Rate: 36 mL/sec
  • Length: 100 Centimeter
ANG106-0105

  • Angiographic catheter, single-use
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