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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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DUROLANE - 00816986020808

DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate- buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.
BIOVENTUS LLC
1082020
In Commercial Distribution

  • 00816986020808 ()
  • 10816986020805 ()
  • 89130-2020-1 ()
1082020

  • Synovial fluid supplementation medium

Element™ Test Strips - 08809115908438

Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908438 ()
  • 8522-0000-23 ()
  • 08809115908445 ()

  • Total Volume: 0.3 Microliter


  • Glucose IVD, kit, electrometry

Element™Plus Test Strips - 08809115908957

Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908964 ()
  • 08809115908957 ()
  • 8522-0000-64 ()

  • Total Volume: 0.3 Microliter


  • Glucose IVD, kit, electrometry

CONTOUR® NEXT - 10301937314015

Control Solution - Level 2. 1 x 2.5 mL.
ASCENSIA DIABETES CARE US INC.
7314
In Commercial Distribution

  • 50301937314013 ()
  • 40301937314016 ()
  • 00301937314018 ()
  • 10301937314015 ()
  • 0193-7314-01 ()
83624818

  • Glucose IVD, control

CONTOUR® - 10301937111010

Control Solution - High, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
7111B
Not in Commercial Distribution

  • 50301937111018 ()
  • 40301937111011 ()
  • 00301937111013 ()
  • 10301937111010 ()
  • 0193-7111-01 ()
6707466

  • Glucose IVD, control

CONTOUR® - 10301937110013

Control Solution - Low, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
7110B
Not in Commercial Distribution

  • 50301937110011 ()
  • 40301937110014 ()
  • 00301937110016 ()
  • 10301937110013 ()
  • 0193-7110-01 ()
6707458

  • Glucose IVD, control

CONTOUR® - 10301937109017

Control Solution - Normal, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
7109B
Not in Commercial Distribution

  • 00301937109010 ()
  • 10301937109017 ()
  • 0193-7109-01 ()
  • 40301937109018 ()
  • 50301937109015 ()
6707431

  • Glucose IVD, control

BREEZE® 2 - 10301931491019

Control Solution - High, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1491A
Not in Commercial Distribution

  • 50301931491017 ()
  • 40301931491010 ()
  • 00301931491012 ()
  • 10301931491019 ()
  • 0193-1491-01 ()
81007218

  • Glucose IVD, control

BREEZE® 2 - 10301931490012

Control Solution - Low, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1490A
Not in Commercial Distribution

  • 50301931490010 ()
  • 40301931490013 ()
  • 00301931490015 ()
  • 10301931490012 ()
  • 0193-1490-01 ()
81007196

  • Glucose IVD, control

BREEZE® 2 - 10301931489016

Control Solution - Normal, 1 x 2.5 mL
ASCENSIA DIABETES CARE US INC.
1489A
Not in Commercial Distribution

  • 50301931489014 ()
  • 40301931489017 ()
  • 00301931489019 ()
  • 10301931489016 ()
  • 0193-1489-01 ()
81007188

  • Glucose IVD, control
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