P03-001-001-A1

Nom de l'organisation

ASPIVIX SA

SRN

CH-MF-000026572

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW999

  Contraindications: Cervix diameter smaller than 26 mm (1.02 in). Severe vaginal bleeding. Visible, symptomatic cervical or vaginal infections. Invasive cervical cancer (cervical carcinoma). Previous cervical surgery, resulting in a cervix deformation (such as Conization/Loop Electro-surgical Excision). Large ectopy or scar tissue, for which it is not possible to find a native tissue suitable for Carevix™ application. Any cervix abnormalities that do not permit a good adaptation of the Suction Head to the cervix, such as, but not limited to, Mullerian anomalies with two cervices, Nabothian cyst, Cervical myomas, Cervical condylomas, Squamous intra-epithelial lesion (Cervical dysplasia), Cervical endometriosis, Cervical tears, Cervical polyp. Hypersensitivity to device materials such as Polycarbonate/Polyester alloy, MABS, and thermoplastic elastomer. Warnings: For single patient use only. CarevixTM may be used multiple times with the same patient during the same gynecological procedure. Inspect the product before use CarevixTM is intended for continuous use for less than 60 minutes. Do not reuse, reprocess, or re-sterilize CarevixTM. It compromises the structural integrity of the device and/or leads to device failure which, in turn, may result in patient injury. Do not attempt to tamper with CarevixTM. Any tampering with CarevixTM may compromise its safety and performance. 5.WARNINGS- Do not use if sterile barrier is damaged or open.- Do not use if the product is damaged or expired.- Do not use the product if dropped on the floor after the sterile barrier has been removed. Precautions: Store in a cool and dry place. Keep away from sunlight, rain, and extreme temperatures. Store at temperature range: 7°C (45°F) – 29°C (85°F) and within relative humidity range: 30% - 60%. Vacuum mechanism is pressure sensitive: Do not use at an altitude higher than 1500 m (4921.26 ft) for optimal suction efficiency.

Marché principal en Allemagne ; disponible dans 1 pays au total.

Commercialisé en Allemagne ; dates par pays non publiées.

Dénomination commerciale

non renseigné

Code d'UDI-DI

07649995423079

Basic UDI-DI

7649995423P03MH

Numéro de référence/catalogue

P03-001-001-A1

Entité d'attribution

GS1

Catégorie de risque

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Suction Cervical Stabilizer

URL des informations complémentaires

https://eifu.aspivix.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12080299GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Ce dispositif n'est actuellement lié à aucun autre dispositif.