VITRIFICATION STRAW

Dénomination commerciale

VITRIFICATION STRAW

00819374021692

081226101VSW08834

Numéro de référence/catalogue

SUL-G

GS1

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

"The SURELOCK Vitrification Straw is a cryopreservation storage device. It is used in the vitrification procedure to contain and maintain oocytes and embryos., Concave tip for exact and secure placement of specimen under microscope, Secure air tight coupling, Semi-transparent body and cap, The arrow on top surface ensuring orientation during use, Easy visibility under microscope, 1 - cell MEA ≥ 80% expand blastocysts within 96h, Endotoxin LAL tested, Sterility: SAL 10⁻⁶ -Gamma sterilized, Vitrification of 1-cell stage of embryos"

URL des informations complémentaires

https://www.allwinmedical.com/e-ifu/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

1 niveau de conditionnement enregistré — chaque niveau porte son propre IUD-ID.

• 00819374021692× 1 unitéUnité de base
  • 10819374021699× 10 unités

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• U080299DEVICES FOR ASSISTED REPRODUCTION - OTHER

6 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Avertissement

  Federal (USA) law restricts this device to sale by or on the order of a physician.

• Ne pas réutiliser
• Ne pas restériliser
• Ne pas utiliser si l’emballage est endommagé
• Ne pas utiliser après la date indiquée
• Warning/ Precaution: • Do not use if package is opened or damaged. • Dispose in accordance with recognized medical practice and under observance of applicable law and regulation. • For vitrification and warming purposes, have all necessary materials, tools and equipment ready and handy before starting procedures. • Before loading 1-cell embryos, verify the integrity of SureLock under a microscope, discarding any SureLock with tips cracked, flush on well or abnormal shapes. • Liquid nitrogen may cause serious harm if in contact with skin or eyes. • Use appropriate precautions and safety devices when work with liquid nitrogen. When plunging SureLock in LN2 always use a separate fresh aliquot LN2 per patient. • Storage temperature between 5ºC to 30ºC. • This device is supplied sterile and intended for single use only. • Do not resterilize. • Only experienced practitioners should use this device.