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510(k) Data Aggregation
K Number
K092398Device Name
HSV STRAW
Manufacturer
CRYO BIO SYSTEM
Date Cleared
2010-10-06
(426 days)
Product Code
MQK, MOK
Regulation Number
884.6160Why did this record match?
Applicant Name (Manufacturer) :
CRYO BIO SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HSV Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 Cell and blastocyst stage embryos.
Device Description
An embryo is vitrified using the HSV Straw by placing an embryo suspended in a 0.5ul All entrification solution solution in a curved polymeric spatula (Medical Grade. Styrene-Butadiene Copolymer). The curved spatula is inserted in an outer straw with a Styrene-Butadiene Coporymer). The open, proximal end of the straw is sealed by the user. The sealed, weighted unsal Chd. The open, promishar effect freezing-vitrification. The weighted straw seated straw is placed in liquid nitrogen for embryo storage. Thawing-rewarming: While the remains in liquid nitrogen, part of the outer tube is cut away. The curved spatial, distal tip tellians in inquir mirogen, part of the outer straw and immediately immersed in thawing solution where thawing and dilution of the remaining vitrification solution occur simultaneously.
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K Number
K002595Device Name
CBS STRAW
Manufacturer
CRYO BIO SYSTEM
Date Cleared
2000-11-17
(88 days)
Product Code
MQG
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
CRYO BIO SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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