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
OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip.
LifeScan Europe GmbH
023-194
In Commercial Distribution

  • 20353885010713 ()
  • 00353885010719 ()
  • 53885-194-01 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
  • Needle Gauge: 30 Gauge
023-194

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-913
In Commercial Distribution

  • 20353885002688 ()
  • 00353885002684 ()
  • 53885-913-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
021-913

  • Glucose analyser IVD, home-use
  • Manual blood lancing device, reusable
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-422
In Commercial Distribution

  • 20353885001315 ()
  • 00353885001311 ()
  • 53885-422-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-422

  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
INTRA-ARTICULAR HYALURONIC ACID. 1 PRE-FILLED SYRINGE CONTAINING 16.8 mg / 2 mL HYALURONIC ACID SODIUM SALT
IBSA FARMACEUTICI ITALIA SRL
GS3111
In Commercial Distribution

  • 08033638951057 ()
  • 89130-3111-1 ()

  • Total Volume: 2.25 Milliliter


  • Synovial fluid supplementation medium
OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-270
In Commercial Distribution

  • 20353885010973 ()
  • 00353885010979 ()
  • 53885-271-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
023-270

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Glucose IVD, kit, electrometry
  • Manual blood lancing device, reusable
  • Blood lancing device tip
OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-658
In Commercial Distribution

  • 20353885008727 ()
  • 00353885008723 ()
  • 53885-658-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
022-658

  • Glucose monitoring system IVD, home-use
  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose IVD, control
OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-657
In Commercial Distribution

  • 20353885008710 ()
  • 00353885008716 ()
  • 53885-657-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
022-657

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-419
In Commercial Distribution

  • 20353885001285 ()
  • 00353885001281 ()
  • 53885-419-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
021-419

  • Glucose analyser IVD, home-use
  • Blood lancing device tip
  • Manual blood lancing device, reusable
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