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510(k) Data Aggregation

    K Number
    K080172
    Device Name
    BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
    Manufacturer
    MEDICULT A/S
    Date Cleared
    2008-12-18

    (329 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICULT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BlastAssist® and BlastAssist® with Phenol Red are used for culture of embryos from the 4-8 cell stage through to blastocyst stage. Can also be used for transfer.
    Device Description
    BlastAssist® and BlastAssist® with Phenol Red are defined sterile media, used by assisted reproduction professionals and intended for culture of embryos from the 4-8 cell stage to blastocyst stage and for embryo transfer. The design of BlastAssist® and BlastAssist® with Phenol Red is based on BlastAssist® System Medium 2 ( K003156). The BlastAssist® medium is a salt solution added SSR (Synthetic Serum Replacement), HSA, ethanolamine, amino acids, a stable form of L-glutamine, vitamins and antibiotics. BlastAssist® is supplied in 10 ml polyethylene plastic vials with screw top closures
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    K Number
    K081639
    Device Name
    ICSI CUMULASE
    Manufacturer
    MEDICULT A/S
    Date Cleared
    2008-09-19

    (100 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICULT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ICSI Cumulase® is for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI.
    Device Description
    ICSI Cumulase is a defined sterile, ready to use media used by professionals within assisted reproduction and intended for the removal of the cumulus complex and corona radiata surrounding the oocyte in preparation for ICSI. ICSI Cumulase is a modified version of SynVitro® Cumulase ( K060699) and is based on a salt solution containing a recombinant hyaluronidase and HSA (US license No 1716). ICSI Cumulase is supplied in transparent polypropylene plastic vials with screw top closures in a volume of 0.5 ml.
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    K Number
    K080473
    Device Name
    EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED
    Manufacturer
    MEDICULT A/S
    Date Cleared
    2008-09-03

    (195 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICULT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EmbryoAssist™ and EmbryoAssist™ with Phenol Red are for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.
    Device Description
    EmbryoAssist™ and EmbryoAssist™ with Phenol Red are each a defined sterile media used by professionals within assisted reproduction and intended for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3. The composition of EmbryoAssist™ and EmbryoAssist™ with Phenol Red are almost identical to The predicate device Embryo Assist™ (K061309), but with an extension of the intended use including a transfer indication. The EmbryoAssist" medium is a salt solution containing SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml and 60 ml polyethylene plastic vials with screw top closures.
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    K Number
    K061309
    Device Name
    EMBRYOASSIST
    Manufacturer
    MEDICULT A/S
    Date Cleared
    2007-02-08

    (274 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICULT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EmbryoAssist™ is used for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes.
    Device Description
    EmbryoAssist™ is a defined sterile medium, used by assisted reproduction professionals and intended for culture of embryos up to the 4-8 cell stage (Day 2 or Day 3 after insemination). The medium can also be used for fertilisation of oocytes. The design of EmbryoAssist™ is based on BlastAssist Medium 1 (MediCult's BlastAssist®System K003156). The EmbryoAssist™ medium is a salt solution added SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml polyethylene plastic vials with screw top closures
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    K Number
    K061145
    Device Name
    SPERMSLOW
    Manufacturer
    MEDICULT A/S
    Date Cleared
    2006-10-02

    (160 days)

    Product Code
    MQL, MOL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICULT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SpermSlow™ is used to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI).
    Device Description
    SpermSlow™ is a defined medium used by professionals within assisted reproduction designed to slow down the movement and to select the most mature, viable sperm as required for Intracytoplasmatic sperm injection (ICSI). SpermSlow wis principally composed of hyaluronate (HA), the main component of the extracellular matrix, which appears in large amounts between the cumulus cells of the matured oocyte-cumulus complex. SpermSlow™ is based on a sodium bicarbonate buffered solution containing hyaluronate, HSA (US licensed source), pyruvate, glucose, amino acids, nucleotides, vitamins and antibiotics. SpermSlow™ is supplied in polypropylene plastic vials with screw top closures in a volume of 0.5ML. Each unit is labelled and the product is presented in four pack containers which also include a package insert.
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    K Number
    K060983
    Device Name
    BIOPSY MEDIUM, MODEL REF 1062
    Manufacturer
    MEDICULT A/S
    Date Cleared
    2006-07-28

    (109 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICULT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biopsy Medium is intended for blastomere biopsy of cleavage stage embryos for PGD (preimplantation genetic diagnosis)
    Device Description
    MediCult Biopsy Medium is a defined sterile media used by professionals within assisted reproduction and designed for blastomere biopsy of cleavage stage embryos for pre-implantation genetic diagnosis (PGD). The formulation is based on a HEPES-buffered HTF solution added SSR (Synthetic Serum Replacement: ART supplement), human serum albumin (HSA) and amino acid but without calcium and magnesium ions to facilitate the process of biopsy. The absence of calcium and magnesium ions reversibly reduces the cellular connection between the blastomeres making it easy to excise a blastomere from the embryo without fatal trauma. Biopsy Medium is supplied in 10 ml polyethylene plastic vials with screw top closures.
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    K Number
    K060699
    Device Name
    SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)
    Manufacturer
    MEDICULT A/S
    Date Cleared
    2006-05-10

    (55 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICULT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SynVitro Cumulase™ is used by professionals within assisted reproduction for the removal of the cell complex (cumulus and corona radiata) surrounding the oocyte in the preparation for intracytoplasmatic sperm injection (ICSI). SynVitro Cumulase™ is indicated for the removal of the cell complex (cumulus and corona radiate) surrounding the oocyte in preparation for the ICSI procedure.
    Device Description
    SynVitro®Cumulase™ is a sterile non preserved solution containing 80 U/mL of recombinant Synther Camandase (rHuPH20) in a HEPES buffered salt solution with SSR (Synthetic serum replacement) added.
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    K Number
    K041284
    Device Name
    MEDICULT IVM SYSTEM
    Manufacturer
    MEDICULT A/S
    Date Cleared
    2004-11-22

    (193 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICULT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAG medium is for pre-incubation of immature oocytes and the IVM Medium is a basal medium for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons can not undergo conventional ovarian stimulation using drugs.
    Device Description
    MediCult IVM® System including Vial 1, LAG Medium and Vial 2 , IVM®Medium. The MediCult IVM® System is a sequential media system including LAG Medium and IVM®Medium which has been developed specifically to support maturation in-vitro of immature oocytes. The composition of the LAG medium is similar to the composition of Universal IVF Medium. Like the Universal IVF Medium the IVM®Medium contains physiological salts and nutritients but differs from this medium by also containing vitamins, amino acids and nucleotides and by being free from human serum albumin.
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    K Number
    K030490
    Device Name
    ISM1+, IMS2+, AND UTM+
    Manufacturer
    MEDICULT A/S
    Date Cleared
    2003-08-20

    (187 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICULT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ISM1+: For culture of embryos. To be used in culture after fertilization in Universal IVF Medium (K 991279) up to Day3 to 6- to8-cell stage, followed by extended culture in ISM2+ or by transfer in UTM+. ISM2+: For culture of embryos. To be used in culture from 6- to 8-cell stage on Day3 to blastocyst stage on day 5, followed by transfer in UTM+. ISM2+ shall be used after ISM1+. UTM+: For transfer of embryos cultured in ISM1+ or ISM2+.
    Device Description
    ISM1+, ISM2+, and UTM+ are sequential media for the culture and transfer of embryos. Their composition includes physiological salts, sodium bicarbonate, Penicillin/Streptomycin, HSA, Glucose and derived metabolites, Nucleosides, Non-essential amino acids, Essential amino acids, Phenol Red, and Vitamins. UTM+ also contains Hyaluronate.
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    K Number
    K031486
    Device Name
    BLASTFREEZE AND BLASTTHAW
    Manufacturer
    MEDICULT A/S
    Date Cleared
    2003-06-27

    (46 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICULT A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BlastFreeze™: For freezing of human blastocysts. BlastThaw™: For thawing of human blastocysts.
    Device Description
    BlastFreeze™ and BlastThawTM, Cat.No. 10532010 and 10542010. BlastFreeze and BlastThaw are based on Earle's Balanced Salts Solution and differing concentrations of sucrose. BlastFreeze contains glycerol as the cryprotectant.
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