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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Precision Xtra Blood Glucose & Ketone Monitoring System
ABBOTT DIABETES CARE INC
98814
In Commercial Distribution

  • 30093815988145 ()
  • 00093815988144 ()
  • 57599-8814-1 ()
98814

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing
LifeScan Europe GmbH
022-268
In Commercial Distribution

  • 20353885007713 ()
  • 00353885007719 ()
  • 53885-854-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
022-268

  • Glucose monitoring system IVD, home-use
  • Glucose IVD, control
  • Manual blood lancing device, reusable
  • Blood lancing device tip
  • Glucose IVD, kit, electrometry
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
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
24 hour maintenance kit for oral care with ReddyPort Elbow. 24 hour maintenance kit includes: 1x prep pack (yankauer), 2x suction silicone toothbrush packs with anti-plaque solution (cetylpyridinium chloride 0.05%), applicator swabs and mouth moisturizer, 4x suction swab packs with suction swab, applicator swab, antiseptic oral rinse (hydrogen peroxide 1.5%) and mouth moisturizer.
SMD Manufacturing LLC
RP-MKITQ4-1
In Commercial Distribution

  • 10850001175217 ()
  • 00850001175210 ()
  • 73573-155-14 ()


  • Oral care kit, single-use
  • Basic manual toothbrush
  • Dental tooth-cleaning solution
  • Oral care swab
OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-932
In Commercial Distribution

  • 20353885011765 ()
  • 00353885011761 ()
  • 53885-932-02 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
023-932

  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Glucose monitoring system IVD, home-use
OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-100
In Commercial Distribution

  • 20353885008857 ()
  • 00353885008853 ()
  • 53885-452-10 ()

  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
021-100

  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose monitoring system IVD, home-use
OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
022-965
In Commercial Distribution

  • 20353885010010 ()
  • 00353885010016 ()
  • 53885-296-01 ()

  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
022-965

  • Glucose IVD, kit, electrometry
  • Glucose analyser IVD, home-use
Zumi 4.5 Uterine Manipulator/Injector
Adler, Inc.
AI-611
In Commercial Distribution

  • 00810123207084 ()
  • 00810123207176 ()


  • Drug-delivery iontophoresis patch
Zami/Kronner 4.5 Uterine Manipulator
Adler, Inc.
AI-6003
In Commercial Distribution

  • 00810123207077 ()
  • 810123207183 ()


  • Liposuction system cannula, reusable
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