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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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Nidacon - 07350025610245

VitriBlast is intended for ultra-rapid freezing of human blastocysts. This kit is designed for use with Nidacon's ThermoBlast Thaw Kit for optimal recovery of specimens. This product is used for Assisted Reproductive Technology (ART.) procedures.
Nidacon International AB
VitriBlast™ Kit
In Commercial Distribution

  • 07350025610245 ()
VBK-010

  • Spermatozoa/semen motility medium supplement

Nidacon - 07350025610238

The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).
Nidacon International AB
PureSperm® Wash
In Commercial Distribution

  • 07350025610238 ()
PSW-020

  • Spermatozoa/semen motility medium supplement

Nidacon - 07350025610184

The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator.
Nidacon International AB
NidOil™
In Commercial Distribution

  • 07350025610184 ()
NO-300

  • Spermatozoa/semen motility medium supplement

Nidacon - 07350025610009

The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).
Nidacon International AB
PureSperm® 40/80
In Commercial Distribution

  • 07350025610009 ()
PSK-020

  • Spermatozoa/semen motility medium supplement

RapidWarm Blast - 07350025914220

No Description
Vitrolife Sweden AB
10120
In Commercial Distribution

  • 07350025914220 ()


  • IVF medium kit

RapidVit Blast - 07350025914213

No Description
Vitrolife Sweden AB
10119
In Commercial Distribution

  • 07350025914213 ()


  • IVF medium kit

G-GAMETE - 07350025914206

No Description
Vitrolife Sweden AB
10126
Not in Commercial Distribution

  • 07350025914206 ()


  • IVF medium

EmbryoGlue - 07350025910901

No Description
Vitrolife Sweden AB
10190
In Commercial Distribution

  • 07350025910901 ()


  • IVF medium

G-MOPS PLUS - 07350025910826

No Description
Vitrolife Sweden AB
10182
In Commercial Distribution

  • 07350025910826 ()


  • IVF medium

G-MOPS - 07350025910819

No Description
Vitrolife Sweden AB
10181
In Commercial Distribution

  • 07350025910819 ()


  • IVF medium
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