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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Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
ASCENSIA DIABETES CARE US INC.
1465A
Not in Commercial Distribution

  • 40301931465509 ()
  • 00301931465501 ()
  • 10301931465508 ()
  • 20301931465505 ()
  • 0193-1465-50 ()
  • 00301931465013 ()
56853212

  • Glucose monitoring system IVD, home-use
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
G5 Touchscreen Receiver
Dexcom, Inc.
STK-SR-001
Not in Commercial Distribution

  • 20386270000327 ()
  • 08627-0090-11 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
G6 Receiver Kit (Retail)
Dexcom, Inc.
STK-OE-001
In Commercial Distribution

  • 00386270001900 ()
  • 08627-0091-11 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
78754
In Commercial Distribution

  • 30357599842001 ()
  • 00357599842000 ()
  • 57599-0842-00 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 Plus Sensor Not For Retail Sale
ABBOTT DIABETES CARE INC
78749
In Commercial Distribution

  • 30357599836000 ()
  • 00357599836009 ()
  • 57599-0836-00 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 2 Plus Sensor
ABBOTT DIABETES CARE INC
78747
In Commercial Distribution

  • 30357599835003 ()
  • 00357599835002 ()
  • 57599-0835-00 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 3 Continuous Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
72079
In Commercial Distribution

  • 57599-0820-00 ()
  • 00357599820008 ()
72079

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 3 Sensor Kit NFRS
ABBOTT DIABETES CARE INC
72080
In Commercial Distribution

  • 30357599819003 ()
  • 00357599819002 ()
  • 57599-0819-00 ()
72080

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
FreeStyle Libre 3 Sensor Kit US
ABBOTT DIABETES CARE INC
72081
In Commercial Distribution

  • 30357599818006 ()
  • 00357599818005 ()
  • 57599-0818-00 ()
72081

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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