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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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INSTANT-VIEW FSH Midstream Cassette Test, 2t
ALFA SCIENTIFIC DESIGNS, INC.
02-2560-2
In Commercial Distribution

  • 10796918002003 ()
  • 00796918002006 ()


  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
INSTANT-VIEW FSH Dip-Strip Test
ALFA SCIENTIFIC DESIGNS, INC.
02-2567
In Commercial Distribution

  • 10796918000146 ()
  • 00796918000149 ()


  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
INSTANT-VIEW FSH Cassette Test
ALFA SCIENTIFIC DESIGNS, INC.
02-2562
In Commercial Distribution

  • 10796918000139 ()
  • 00796918000132 ()


  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Single piece of plastic with a handle and a head used to scrape tongue for oral hygiene. 100 pack
PRACTICON, INC.
53c2008a
In Commercial Distribution

  • 00723896023686 ()
  • 00723896023679 ()
2039715

  • Tongue scraper, reusable
Menopause Test - 1 Test
SYNTRON BIORESEARCH, INC.
Midstream
In Commercial Distribution

  • 10748349000707 ()
  • 00748349000700 ()


  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Stork® OTC packages include: Instructions for Use (IFU), one Conceptacle® and one plastic applicator. Once the couple has decided to attempt to become pregnant, the Stork® OTC Conception System Instruction for Use recommends using the device during female’s most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle®, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle® from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cap is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervix. When the cervical cap is loaded onto the applicator (while it is still outside of the body), the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intra-vaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.
STORK IB2C, INC., THE
USOTC
In Commercial Distribution

  • 00810396020007 ()


  • Conceptive cervical cap, single-use
Vashe® Wound Solution OTC is a wound cleansing solution that is intended for cleansing, irrigating, debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. Vashe® Wound Solution OTC is intended for OTC use for management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
URGO MEDICAL NORTH AMERICA, LLC
00405
In Commercial Distribution

  • 10190769004054 ()
  • 00190769004057 ()

  • Total Volume: 250 Milliliter
00405

  • Antimicrobial wound irrigation solution
External Penile Rigidity Device that contains kit bag, manual vacuum pump, battery vacuum pump,constriction rings, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007127 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, battery vacuum pump, tension systems, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007110 ()


  • Penile vacuum device
Battery Vacuum Pump
AUGUSTA MEDICAL SYSTEMS, L.L.C.
Battery Vacuum Pump
In Commercial Distribution

  • 00852598007059 ()


  • Penile vacuum device
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