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510(k) Data Aggregation
K Number
K172751Device Name
iVitri Straw
Manufacturer
Date Cleared
2018-02-09
(150 days)
Regulation Number
884.6160Why did this record match?
Applicant Name (Manufacturer) :
Reprobitech Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iVitri®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
The iVitri® Straw device 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. The iVitri® Straw device consists of a square-shaped polystyrene stick and acrylonitrile butadiene styrene (ABS) cap. As part of the vitrification procedure, the embryos are loaded on the tip of the stick, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during handling procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only.
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K Number
K162640Device Name
iVitri EZ
Manufacturer
Date Cleared
2017-06-30
(281 days)
Regulation Number
884.6160Why did this record match?
Applicant Name (Manufacturer) :
REPROBITECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iVitri® EZ 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
The iVitri®EZ device 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. The iVitri® EZ device is composed of a twopiece polystyrene assembly with a square-shaped stick (body) and cap. As part of the vitrification procedure, the embryos are loaded on the tip, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only.
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