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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The Sure + is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women and to maintain urinary continence in women. The Sure + is intended for OTC use.
TENSCARE LIMITED
Sure+
In Commercial Distribution

  • 05033435134458 ()
K-SURE+USA

  • Perineal orifice incontinence-control electrical stimulation system
The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. The EASY MAX Glucose Test Strips must be used with the EASY MAX Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
EPS BIO TECHNOLOGY CORP.
EASY MAX
In Commercial Distribution

  • 10885017000277 ()
  • 00885017000270 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. The test Strips must be used with the EASY MAX 15 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, is not for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can only be used during steady-state blood glucose conditions.
EPS BIO TECHNOLOGY CORP.
EASY MAX 15
In Commercial Distribution

  • 10885017000284 ()
  • 00885017000287 ()


  • Glucose IVD, kit, enzyme spectrophotometry, rapid
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