LEFT SAM·MAS KIT

Nom de l'organisation

VEC MEDICAL SPAIN, S.L.

SRN

ES-MF-000002992

Statut du fabricant

Actif

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• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW032

  EUDAMED n'a pas publié de description pour ce code.
• CW999

  Disinfect the device with medical specific instrument disinfectant after each use to avoid the risks of contamination and infection in the patient. The immersion time of the device depends on the disinfectant used. After disinfection, remove the disinfectant products with water and dry the device meticulously.
• CW999

  Dental trays and forks are for single use, do not reuse. To reuse them may cause infection
• CW999

  The dental trays and forks do not have any functionality on their own, they must be used together with the device.
• CW999

  Do not use if the product is damaged.
• CW999

  The recommended number of device uses is 100.
• CW999

  The product should only be used by skilled health professionals trained in the technique.
• CW999

  Do not use outside of its indicated use.
• CW999

  CONTRAINDICATIONS: Absence of dental support, limited protrusive movement, severe temporomandibular disorder or presence of fixed orthodontics.

Marché principal en Espagne ; disponible dans 6 pays au total.

Dénomination commerciale

LEFT SAM·MAS KIT

Code d'UDI-DI

08436570232183

Basic UDI-DI

84365702328TE

Numéro de référence/catalogue

28001_L-kit

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

Mandibular Advancement Selector. The SAM·MAS® is a Mandibular Advancement Selector device with multiple uses for different patients. The device requires single-use accessories that are attached for use and detached when no longer needed. Its design and geometry allow it to be attached to the patient's mouth and manipulate the jaw in terms of protrusion/retrusion and mouth opening.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• Left

• Q03010299ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER

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