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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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ACCUSYNC 72 3 LEAD CARDIAC TRIGGER MONITOR WITH PRINTER OPTION
Accusync Medical Research Corporation
7200-3P
In Commercial Distribution

  • 00860008802033 ()
7200-3P

  • Patient monitoring system module, cardiac output
ACCUSYNC 72 3-LEAD CARDIAC TRIGGER SYSTEM
Accusync Medical Research Corporation
7200-3
In Commercial Distribution

  • 00860008802026 ()
7200-3

  • Patient monitoring system module, cardiac output
Infant Stabilizer Straps
Smoltap, Inc.
STSTR1
In Commercial Distribution

  • 10860008770612 ()
  • 00860008770615 ()
STSTR1

  • Infant limb immobilizer, reusable
Infant Stabilizer
Smoltap, Inc.
STCR1
In Commercial Distribution

  • 00860008770608 ()
STCR1

  • Infant limb immobilizer, reusable
Cool Blue™ Nitrile Gloves, Powder Free, Medium
Stellar Scientific, LLC
GLV-CB-M
In Commercial Distribution

  • 10860008768244 ()
  • 00860008768247 ()

  • Medium
GLV-CB-M

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Cool Blue™ Nitrile Gloves, Powder Free, Large
Stellar Scientific, LLC
GLV-CB-L
In Commercial Distribution

  • 10860008768237 ()
  • 00860008768230 ()

  • Large
GLV-CB-L

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Cool Blue™ Nitrile Gloves, Powder Free, Small
Stellar Scientific, LLC
GLV-CB-S
In Commercial Distribution

  • 10860008768206 ()
  • 00860008768209 ()

  • Small
GLV-CB-S

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
The Know Rapid STD Screening Kit (Urine Test Cassette) includes individual test cassettes for: 1. Chlamydia Trachomatis (CHT) 2. Neisseria Gonorrhoeae (NGH) 3. Trichomonas Vaginalis (TV) 4. Mycoplasma Genitalium (MG). Each test strip in the cassette is suitable for urine specimen tests. During testing, if a specific antigen presented in the urine specimen reacts with each test cassette in the T reagent area, the conjugate antigens complex will be bound with the test cassette’s antibody coated on the membrane in case of a positive result. This would show in a dark red colored line in the T line region of a positive result. In case of negative result, no conjugate would bind at the test cassette’s antibody in the T line region and no line would form in the T line region of the test membrane. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. Absence of C line indicates an invalid test result.
MobiLab Medical Innovatives Inc.
MSSH
Not in Commercial Distribution

  • 00860008737359 ()


  • Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
The MobiLab Standard Sexual Health Self Screening Kit (urine specimen) includes individual test cassettes for: 1. Trichomonas Vaginalis (TV) 2. Candida Albicans (Yeast) (CA) 3. Gardnerella Vaginalis (GV) 4. Mycoplasma Genitalium (MG) 5. Chlamydia Trachomatis (CHT) 6. Neisseria Gonorrhoeae (NGH). Each test strip in the cassette is suitable for urine specimen tests. During testing, if a specific antigen presented in the urine specimen reacts with each test cassette in the T reagent area, the conjugate antigens complex will be bound with the test cassette’s antibody coated on the membrane in case of a positive result. This would show in a dark red colored line in the T line region of a positive result. In case of negative result, no conjugate would bind at the test cassette’s antibody in the T line region and no line would form in the T line region of the test membrane. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. Absence of C line indicates an invalid test result.
MobiLab Medical Innovatives Inc.
MSSH
Not in Commercial Distribution

  • 00860008737304 ()


  • Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use
Patient specific, 3D printed, single use postoperative nasal splints to control edema based a patient’s treatment plan. RX only, non-diagnostic.
Mirrorme3d, LLC
MSTL
In Commercial Distribution

  • 00860008704191 ()


  • External nasal splint
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