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Found 26 results
510(k) Data Aggregation
K Number
K080172Device 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
884.6180Why 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
K081639Device Name
ICSI CUMULASE
Manufacturer
MEDICULT A/S
Date Cleared
2008-09-19
(100 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why 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
K080473Device Name
EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED
Manufacturer
MEDICULT A/S
Date Cleared
2008-09-03
(195 days)
Product Code
MQL
Regulation Number
884.6180Why 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
K061309Device Name
EMBRYOASSIST
Manufacturer
MEDICULT A/S
Date Cleared
2007-02-08
(274 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why 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
K061145Device Name
SPERMSLOW
Manufacturer
MEDICULT A/S
Date Cleared
2006-10-02
(160 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why 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
K060983Device Name
BIOPSY MEDIUM, MODEL REF 1062
Manufacturer
MEDICULT A/S
Date Cleared
2006-07-28
(109 days)
Product Code
MQL
Regulation Number
884.6180Why 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
K060699Device Name
SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)
Manufacturer
MEDICULT A/S
Date Cleared
2006-05-10
(55 days)
Product Code
MQL
Regulation Number
884.6180Why 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
K041284Device Name
MEDICULT IVM SYSTEM
Manufacturer
MEDICULT A/S
Date Cleared
2004-11-22
(193 days)
Product Code
MQL
Regulation Number
884.6180Why 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
K030490Device Name
ISM1+, IMS2+, AND UTM+
Manufacturer
MEDICULT A/S
Date Cleared
2003-08-20
(187 days)
Product Code
MQL
Regulation Number
884.6180Why 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
K031486Device Name
BLASTFREEZE AND BLASTTHAW
Manufacturer
MEDICULT A/S
Date Cleared
2003-06-27
(46 days)
Product Code
MQL
Regulation Number
884.6180Why 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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