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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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Almost Naked Hint of Mint - 00850014621940

Almost Naked Hint of Mint is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
1.69oz
In Commercial Distribution

  • 00850014621940 ()
  • 10850014621947 ()
700350

  • Sexual lubricant

Hybrid Lubricant - 00850014621780

Hybrid Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
5 mL
In Commercial Distribution

  • 30850014621781 ()
  • 00850014621780 ()
  • 00850044065042 ()
200501

  • Sexual lubricant

Liquid Lubricant - 00850014621773

Liquid Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
5 mL
In Commercial Distribution

  • 30850014621774 ()
  • 00850014621773 ()
  • 00850044065035 ()
200500

  • Sexual lubricant

Hybrid Lubricant - 00850014621568

Hybrid Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
1.69oz
In Commercial Distribution

  • 00850014621575 ()
  • 00850014621568 ()
  • 30850014621569 ()
700250

  • Sexual lubricant

Liquid Lubricant - 00850014621544

Liquid Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
1.69oz
In Commercial Distribution

  • 30850014621545 ()
  • 00850014621544 ()
700150

  • Sexual lubricant

BioNourish Vaginal Gel - 00850014621070

BioNourish Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
5 mL
In Commercial Distribution

  • 30850014621071 ()
  • 00850014621070 ()
  • 00850044065028 ()
  • 00850044065127 ()
200601

  • Sexual lubricant

SIR-Spheres Y-90 resin microspheres - 00850014612146

SIR-Y002 (1.8Gbq/3ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 1.8 GBq of Y90 ± 10% (at the time of calibration) in a total of 3 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y002
In Commercial Distribution

  • 00850014612146 ()

  • Total Volume: 3 Milliliter


  • Manual brachytherapy source, permanent implant

SIR-Spheres® Microspheres Activity Calculator (SMAC) - 00850014612108

Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
SIRTEX MEDICAL PTY LTD
X-SMAC-01
In Commercial Distribution

  • 00850014612108 ()


  • Clinical management support software

SIR-Spheres Accessories Pack - 00850014612092

Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)
SIRTEX MEDICAL PTY LTD
SIR-K002
In Commercial Distribution

  • 00850014612092 ()


  • General-purpose brachytherapy system applicator, manual

SIR-Spheres Syringe Shield - 00850014612085

SIR-Spheres Syringe Shield
SIRTEX MEDICAL PTY LTD
SIR-S001
In Commercial Distribution

  • 00850014612085 ()


  • Syringe radiation shield
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