649.000000

Nom de l'organisation

AKRUS GmbH & Co. KG

SRN

DE-MF-000005262

Statut du fabricant

Actif

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

• CW010

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

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

04260647941579

Basic UDI-DI

426064794SCSB5010surgeS8

Numéro de référence/catalogue

649.000000

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

The mobile, electrically operated operating tables are designed for placement and positioning of patients in the required posture during diagnostic and therapeutic procedures as well as during surgical interventions on humans. The product enables optimal access to the patient's head in its various positions and is intended for use in the following medical fields: • Ophthalmology • ENT (ear, nose and throat) • Oral and maxillofacial surgery • Plastic, reconstructive and aesthetic surgery, primarily in the head area • Dentistry • Dermatology • Nerve stimulation • Blood donation Due to its design, functionality and accessories, the surgical chair only allows the following positioning of patients: • Supine position • Sitting position • Beach chair position • Prone position • Shock position: Zero position and Trendelenburg position. The surgical chair is designed for patients weighing a maximum of 200 kg or 300 kg, depending on the variant. The headrest is designed to support a maximum weight of 20 kg. The operating tables are only intended for positioning patients immediately before, during and after a procedure/surgical intervention and for short-distance transportation for transfer purposes along with a safety rail or patient fixation belt. Positioning may only be carried out by appropriately trained specialist personnel. The product is suitable for use in the immediate controlled patient environment. The essential performance of the product is given by no movement during first error situations.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12011201OPERATING CHAIRS

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