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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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NATALIST OVULATION TEST MIDSTREAM 10 COUNT is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. There are 10pcs of 6mm midstreams in each box.
Equinox Biotech Co., Ltd.
58042
In Commercial Distribution

  • 00850014758042 ()
RH-LH-B

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
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 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 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 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 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
Restore is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
GOOD CLEAN LOVE, INC.
2 oz
In Commercial Distribution

  • 30850014621477 ()
  • 00850014621476 ()
900300

  • General-body orifice lubricant, non-sterile
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-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
Dose activity calculator for Selective Internal Radiation Therapy (SIRT)
SIRTEX MEDICAL PTY LTD
X-SMAC-01
In Commercial Distribution

  • 00850014612108 ()


  • Clinical management support software
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
SIRTEX MEDICAL PTY LTD
SIR-S001
In Commercial Distribution

  • 00850014612085 ()


  • Syringe radiation shield
SIR-Spheres V-Vial Holder
SIRTEX MEDICAL PTY LTD
SIR-H001
In Commercial Distribution

  • 00850014612078 ()


  • Vial radiation shield
SIR-Spheres V-Vial
SIRTEX MEDICAL PTY LTD
SIR-V001
In Commercial Distribution

  • 00850014612061 ()


  • General-purpose brachytherapy system applicator, manual
Sir-Spheres delivery set
SIRTEX MEDICAL PTY LTD
SIR-D001
In Commercial Distribution

  • 00850014612054 ()


  • General-purpose brachytherapy system applicator, manual
Delivery Apparatus for the administration of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-B001
In Commercial Distribution

  • 00850014612047 ()


  • Radiation shielding container, general-purpose
SIR-Y001 (3Gbq/5ml): 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 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 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-Y001
In Commercial Distribution


  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant
Sterile disposable tubing designed to provide proper routing of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-10300
In Commercial Distribution

  • 00850014612023 ()
SIR-10300

  • General-purpose brachytherapy system applicator, manual
Set for the preparation of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-10200
In Commercial Distribution

  • 00850014612016 ()
SIR-10200

  • General-purpose brachytherapy system applicator, manual
  • Vial radiation shield
Delivery Dome for the administration of SIR-Spheres
SIRTEX MEDICAL PTY LTD
SIR-10100
In Commercial Distribution

  • 00850014612009 ()
SIR-10100

  • Radiation shielding container, general-purpose
Bio-Reign 3D Block 14mm x 10mm x 14mm
ROYAL BIOLOGICS INC.
BR-b14x10x14
In Commercial Distribution

  • 00850014593773 ()
BR-b14x10x14

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 125mm x 5mm
ROYAL BIOLOGICS INC.
BR-s25x125x5
In Commercial Distribution

  • 00850014593766 ()
BR-s25x125x5

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 75mm x 5mm
ROYAL BIOLOGICS INC.
BR-s25x75x5
In Commercial Distribution

  • 00850014593759 ()
BR-s25x75x5

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 50mm x 5mm
ROYAL BIOLOGICS INC.
BR-s25x50x5
In Commercial Distribution

  • 00850014593742 ()
BR-s25x50x5

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 25mm x 5mm
ROYAL BIOLOGICS INC.
BR-s25x25x5
In Commercial Distribution

  • 00850014593735 ()
BR-s25x25x5

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 125mm x 3mm
ROYAL BIOLOGICS INC.
BR-s25x125x3
In Commercial Distribution

  • 00850014593728 ()
BR-s25x125x3

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 75mm x 3mm
ROYAL BIOLOGICS INC.
BR-s25x75x3
In Commercial Distribution

  • 00850014593711 ()
BR-s25x75x3

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 50mm x 3mm
ROYAL BIOLOGICS INC.
BR-s25x50x3
In Commercial Distribution

  • 00850014593704 ()
BR-s25x50x3

  • Synthetic bone graft
Bio-Reign 3D Sheet 25mm x 25mm x 3mm
ROYAL BIOLOGICS INC.
BR-s25x25x3
In Commercial Distribution

  • 00850014593698 ()
BR-s25x25x3

  • Synthetic bone graft
Bio-Reign 3D Granules 30cc
ROYAL BIOLOGICS INC.
BR-G30
In Commercial Distribution

  • 00850014593681 ()
BR-G30

  • Synthetic bone graft
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