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510(k) Data Aggregation
K Number
K131145Device Name
PROINSERT
Manufacturer
NIDACON INTERNATIONAL AB
Date Cleared
2014-02-20
(303 days)
Product Code
MQK
Regulation Number
884.6160Why did this record match?
Applicant Name (Manufacturer) :
NIDACON INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProInsert™ is used during preparation of human sperm from a semen sample using density gradient separation during assisted reproductive procedures. ProInsert™ facilitates density gradient preparation and pellet retrieval following density gradient separation.
Device Description
ProInsert™ is packaged in a sterile pouch, is single-use only, and includes the following components: Two 15 mL Conical Centrifuge tubes (one for the density gradient preparation and one for washing) 2 Pellet Retrieval Pipettes 1 ProInsert™
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K Number
K092107Device Name
VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010
Manufacturer
NIDACON INTERNATIONAL AB
Date Cleared
2010-06-15
(336 days)
Product Code
MQL, MOL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
NIDACON INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VitriBlast is intended for ultra-rapid freezing (vitrification) of human blastocysts. This kit is designed for use with Nidacon's ThermoBlast kit for optimal recovery of specimens. This product is used for assisted reproduction-technology procedures.
ThermoBlast is intended for the recovery of human blastocysts that have undergone ultra-rapid freezing (vitrification) using Nidacon's VitriBlast kit. It is designed for optimal thawing and recovery of the specimens. This product is used for assisted reproduction-technology procedures.
Device Description
VitriBlast consists of 5 separate vials as described hereunder:
- VitriBlast 1: 10mL based on PureSperm Wash (K002630), with additional hSA.
- VitriBlast 2: 10mL same as solution 1, plus Ethylene glycol (7.5%) and DMSO (7.5%) both provided for separate addition.
- VitriBlast 3: 10mL same as solution 1, including Sucrose (0.67 M) and Ficoll (0.14 mM), plus Ethylene glycol (15%) and DMSO (15%), both provided for separate addition just prior to use.
ThermoBlast consists of 4 separate, 10 mL vials as follows:
- ThermoBlast 4: based on VitriBlast I with additional sucrose (0.33 M).
- ThermoBlast 5: based on VitriBlast I with additional sucrose (0.21 M).
- ThermoBlast 6: the same as VitriBlast | (2 vials).
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K Number
K023206Device Name
SPERM CRYOPROTEC
Manufacturer
NIDACON INTERNATIONAL AB
Date Cleared
2002-11-08
(44 days)
Product Code
MQL, REP
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
NIDACON INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is intended to be used cryopreservative for protecting human sperm during cryopreservation, an adjunct to one of the techniques for ART (assisted reproductive technology).
Device Description
Sperm CryoProtec™ is a buffered salt solution containing human serum albumin and glycerol (10%), has a stable shelf-life of at least 12 months in the unopened bottle at ambient temperature. The product has extremely low endotoxin levels, protects sperm during cryopreservation, and is produced according to cGMP (pharmaceutical device registration). No material of animal origin is included in the product and no antibiotics are present, since antibiotics can have a detrimental effect on sperm. Glycerol, which is also toxic to sperm, is present at the lowest concentration found to be compatible with a cryoprotectant effect.
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K Number
K022443Device Name
SPERMASSIST
Manufacturer
NIDACON INTERNATIONAL AB
Date Cleared
2002-08-28
(34 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
NIDACON INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011607Device Name
SPERMCATCH
Manufacturer
NIDACON INTERNATIONAL AB
Date Cleared
2001-08-10
(78 days)
Product Code
MQL, REP
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
NIDACON INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is intended to be used for decreasing the motility and movements of sperm before ICSI.
SpermCatch™ is a medium designed to modulate sperm motility in a physiological manner, to facilitate injecting a single sperm into an oocyte (ICSI). ICSI is an available procedure in Assisted Reproduction Technology (ART).
Device Description
SpermCatch is optimised for slowing sperm motility prior to ICSI and is ready-to-use in direct replacement for PVP products. SpermCatch is supplied as a sterile (filtered), isotonic salt solution. Volume 5x100 uL. Product No. SC-100
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K Number
K012123Device Name
NIDOIL
Manufacturer
NIDACON INTERNATIONAL AB
Date Cleared
2001-08-03
(28 days)
Product Code
MQL, REP
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
NIDACON INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Assisted Reproduction Technology) and during manipulations outside the incubator.
Device Description
NidOil™ is a light, highly purified, paraffin oil product to be used as an overlay for gamete and embryo culture in the incubator, and for manipulations outside the incubator. Shelf life of two years from production date in unopened bottle Spec. density of 0.82 - 0.87 glcm; Dynamic viscosity (20 ℃) 25.0 - 80.0 mPas Cinematic viscosity (40 ℃) < 33.5 mm 2/s MEA tested Sterilized by filtration during aseptic filling Packaged in amber borosilicate glass bottles with silicone stoppers and Tamper-proof seals Storage of unopened bottles at ambient temperature Opened bottles can also be stored at ambient temperature, if opened only under sterile conditions. NidOil™ is CE marked in countries of the European Union. It is supplied in 100 and 250 ml bottles.
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K Number
K011606Device Name
PURESPERM BUFFER
Manufacturer
NIDACON INTERNATIONAL AB
Date Cleared
2001-07-12
(49 days)
Product Code
MQL, REP
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
NIDACON INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is intended to be used for diluting PureSperm® (K980814 and K984172) sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®.
Device Description
PureSperm® Buffer is supplied as a sterile (autoclaved SAL 10-3) isotonic salt solution. It is optimised for the dilution of PureSperm® or PureSperm® 100 in the preparation of density centrifugation gradients for separating and purifying human sperm. Two layers are commonly used for the gradient: 40% and 80%. This system effectively isolates the best sperm from lymphocytes, epithelial cells, abnormal or immature sperm, cell debris and bacteria. PureSperm® Buffer is CE marked in countries of the European Union. It is supplied in 100 and 250 ml bottles.
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K Number
K011346Device Name
READYSWIM
Manufacturer
NIDACON INTERNATIONAL AB
Date Cleared
2001-06-28
(57 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
NIDACON INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002630Device Name
PURESPERM WASH
Manufacturer
NIDACON INTERNATIONAL AB
Date Cleared
2000-11-21
(90 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
NIDACON INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002623Device Name
PURESPERM 40 AND PURESPERM 80
Manufacturer
NIDACON INTERNATIONAL AB
Date Cleared
2000-11-20
(89 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
NIDACON INTERNATIONAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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