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510(k) Data Aggregation
K Number
K241833Device Name
V-GRAD
Manufacturer
VITROMED GmbH
Date Cleared
2025-03-21
(269 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROMED GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-GRAD is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures.
Device Description
V-GRAD is a sterile colloidal suspension with silicate particles, stabilized with covalently bound hydrophilic silanes that is intended for separation of motile sperm from ejaculates by the density gradient method for use in assisted reproduction procedures. Available as a 100 % stock solution (V-GRAD 100) and as 40% or 80% ready-to-use solutions (V-GRAD 40 and V-GRAD 80) with HEPES buffered Human Tubular Fluid (HTF) medium. V-GRAD 100 is a stock solution for preparing a density gradient system for semen preparation. The V-GRAD Kit consists of two bottles of V-GRAD 40 and V-GRAD 80. V-GRAD is aseptically filtered and provided in pre-sterilized 12 mL glass bottles closed with flourotec rubber stoppers and flip-tear off caps or 100 mL PET(G) bottles closed with HDPE screw caps. V-GRAD has a shelf-life of one year when stored at 2-8°C and can be used for up to seven days after bottle opening.
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K Number
K240176Device Name
V-VITFREEZE and V-VITWARM
Manufacturer
VITROMED GmbH
Date Cleared
2024-09-13
(234 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROMED GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-VITFREEZE is intended for use in the vitrification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
V- VITWARM is intended for use in the thawing of vitrified of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Device Description
V-VITFREEZE AND V-VITWARM include a set of five media intended for use in the vitrification and thawing of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos as part of InVitro Fertilization (IVF) procedures.
V-VITFREEZE (2mL vials) includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose (only in VS), and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS.
Using this methodology, the permeating cryoprotectants can replace water in the oocyte or PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.
V-VITWARM (4mL vials) is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. It is composed of Thawing Solution (TS), Diluent Solution (DS) and Washing Solution (WS).
The base medium for the vitrification and thawing media includes water, salts, buffering agents, minerals, chelating agents, energy substrates, amino acids, hydroxypropyl cellulose, polymeric substance, gentamicin, and phenol red. Cryoprotectants in the media include ethylene glycol, (7.5% in ES and 15% in VS), DMSO (7.5% in ES and 15% in VS), and trehalose in VS, TS, and DS.
The five solutions in the V-VITFREZE and V-VITWARM kit are aseptically filtered (storage vials sterilized by radiation) and provided in polypropylene vials with high density polyethylene screw caps. They have a shelf-life of 12 months when stored at 2-8℃. Media in the vials can be used for up to seven days after vial opening.
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K Number
K232125Device Name
V-PVP
Manufacturer
VITROMED GmbH
Date Cleared
2024-03-20
(247 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROMED GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-PVP is intended for use as an aid in the immobilization of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
Device Description
V-PVP is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracvtoplasmic sperm iniection (ICSI) procedures.
V-PVP is a clear solution with a formulation consisting of polyvinylpyrrolidone, human serum albumin, physiological salts, HEPES Human Tubal Fluid (HTF), pyruvate, lactate, qlucose, and gentamicin. This product is aseptically filtered into 2 mL bottles with caps made from polypropylene copolymer and is provided in a volume of 0.5 mL. V-PVP has a one-year shelf-life when stored as recommended and can be used for up to seven days after opening.
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K Number
K222606Device Name
V-HYADASE
Manufacturer
VITROMED GmbH
Date Cleared
2023-05-26
(270 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
VITROMED GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-HYADASE is intended for the enzymatic removal of cumulus and corona radiata cells from oocytes prior to intracytoplasmic sperm injection (ICSI) procedures.
Device Description
V-HYADASE is an assisted reproduction medium intended for the enzymatic removal of cumulus and corona radiata cells from oocyte prior to Intracytoplasmic Sperm Injection (ICSI) procedures. The medium is aseptically filtered and provided in a volume of 1 mL in pre-sterilized 2 mL polypropylene copolymer (PPCO) bottles with PPCO caps. V-HYADASE has a shelf-life of one-year when stored at 2-8°C and can be used for up to seven days after bottle opening.
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K Number
K223117Device Name
V-SPERM WASH
Manufacturer
Vitromed GmbH
Date Cleared
2023-01-31
(120 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Vitromed GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K193285Device Name
V-ONESTEP
Manufacturer
Vitromed GmbH
Date Cleared
2020-11-20
(359 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
Vitromed GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-ONESTEP is intended for the in vitro culture of human embryos following fertilization until day 5/6 of development.
Device Description
V-ONESTEP is a medium for culturing human embryos following fertilization up to day 6 of development. The device is provided sterile-filtered into pre-sterilized 20 ml glass or 10 ml PETG bottles. V-ONESTEP has a shelf-life of 90 days when stored at 2-8°C and can be use for seven days after opening bottles.
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K Number
K192146Device Name
V-DENUPET
Manufacturer
Vitromed GmbH
Date Cleared
2020-01-28
(173 days)
Product Code
MQH
Regulation Number
884.6130Why did this record match?
Applicant Name (Manufacturer) :
Vitromed GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-DENUPET is used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of oocytes and embryos during assisted reproductive techniques (ART). V-DENUPET is not intended for biopsy of cells from oocytes or embryos.
Device Description
The V-DENUPET is a polycarbonate micropipette. All tips are 90 mm in length, and depending on the size of the tip have a volumetric capacity of 20-25 µl. All pipettes have an outer diameter of 900 µm at the proximal end that is connected to an aspiration device.
The V-DENUPET is supplied in a range of inner diameter sizes at the distal end as shown below:
- Sizes 125 µm, 135 µm, 140 µm, 150 µm, and 175 µm are suitable for oocyte . denudation.
- Sizes 175 µm, 200 µm, 275 µm, 300 µm, and 600 µm are suitable for oocyte . and embryo handling.
V-DENUPET micropipettes are radiation sterilized and provided in a sterile pouch containing a polypropylene vial containing 10 micropipettes. Each pipette is for single-use only.
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