Nidacon SA-020

GUDID 07350025610139

The product is intended to be used for solution for re-suspending sperm after density gradient preparation, for use in intra-uterine insemination, on

Nidacon International AB

Spermatozoa/semen motility medium supplement
Primary Device ID07350025610139
NIH Device Record Keyd0bb1c2e-0708-4b89-93c3-a90ca08a329c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNidacon
Version Model NumberSpermAssist™
Catalog NumberSA-020
Company DUNS631825841
Company NameNidacon International AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+46317030630
Emailcontact@nidacon.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350025610139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-15

On-Brand Devices [Nidacon]

07350025610399The product is intended to be used for the separation and purification of spermatozoa by density
07350025610252Nidacon's ThermoBlast Thaw Kit for intended to be used with Nidacon’s VitriBlast for optimal r
07350025610245VitriBlast is intended for ultra-rapid freezing of human blastocysts. This kit is designed for u
07350025610238The product is intended to be used for the separation and purification of spermatozoa by density
07350025610191An optimized staining technique for assessment of sperm vitality. For use with Assisted Reprodu
07350025610184The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Ass
07350025610177The product is intended for use as an oil overlay during gamete and embryo culture for ART, (Ass
07350025610153The product is intended to be used as a cryopreservative for protecting human sperm during cryop
07350025610146SpermCatch is a medium designed to modulate sperm motility in a physiological manner, to facilit
07350025610139The product is intended to be used for solution for re-suspending sperm after density gradient
07350025610092The product is intended to be used for the separation and purification of spermatozoa by density
07350025610085The product is intended to be used as an accessory for the separation and purification of human
07350025610078The product is intended to be used as an accessory for the separation and purification of human
07350025610061The product is intended to be used for diluting PureSperm® sperm separation medium to prepare
07350025610054The product is intended to be used for the separation and purification of spermatozoa by density
07350025610047The product is intended to be used for the separation and purification of spermatozoa by density
07350025610030The product is intended to be used for the separation and purification of spermatozoa by density
07350025610023The product is intended to be used for the separation and purification of spermatozoa by density
07350025610016The product is intended to be used for the separation and purification of spermatozoa by density
07350025610009The product is intended to be used for the separation and purification of spermatozoa by density

Trademark Results [Nidacon]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NIDACON
NIDACON
88274286 5947817 Live/Registered
Nidacon International AB
2019-01-24
NIDACON
NIDACON
77128754 3555845 Dead/Cancelled
Nidacon International AB
2007-03-12
NIDACON
NIDACON
75302663 2261457 Dead/Cancelled
NidaCon Laboratories AB
1997-06-03

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