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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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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
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Advamedica Inc.
AG4010
In Commercial Distribution

  • 00860008768674 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Advamedica Inc.
AG1010
In Commercial Distribution

  • 00860008768650 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Advamedica Inc.
AG150
In Commercial Distribution

  • 00860008768636 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
Prescription Use - The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. OTC Use - The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.
Advamedica Inc.
AG300
In Commercial Distribution

  • 00860008768612 ()


  • Chitosan haemostatic agent, professional, non-bioabsorbable
The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use.
Equinox Biotech Co., Ltd.
80074
Not in Commercial Distribution

  • 06938444980074 ()
  • 06938444980098 ()
RH-LH-B

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use.
Equinox Biotech Co., Ltd.
80043
Not in Commercial Distribution

  • 06938444980043 ()
  • 06938444980111 ()
RH-LH-S01

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use.
Equinox Biotech Co., Ltd.
RH-LH-B
Not in Commercial Distribution

  • 06938444980036 ()
RH-LH-B

  • Natural conception assistance kit
Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only.
Sugentech Inc._Osong Branch
SU-DR01-LH
In Commercial Distribution

  • 08809408860863 ()
  • 08809408860245 ()
HLHM020E

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Surearly™ Digital OvulationTest in an in vitro diagnostic medical devices for the rapid determination of Luteinizing Hormone (LH) in urine. The test is for the qualitative detection of LH to predict a woman’s most fertile period. It is intended for non-professional, over-the-counter (OTC) use only.
Sugentech Inc._Osong Branch
SU-DR01-LH
In Commercial Distribution

  • 08809408860870 ()
  • 08809408860214 ()
HLHM007E

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
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