NeoNavia FlexiPulse probe

Nom de l'organisation

Neonavia AB

SRN

SE-MF-000045971

Statut du fabricant

Actif

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

• CW999

  NeoNavia® is for diagnostic use only and is not indicated for therapeutic use. NeoNavia® is contraindicated for those patients where increased risk of complications may be associated with percutaneous removal of tissue samples upon the physician’s judgment. Patients receiving anticoagulant therapy or who may have bleeding disorders may be at increased risk.
• CW010

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

  Potential complications are those associated with any percutaneous removal/biopsy technique for tissue collection. Potential complications are limited to the region surrounding the biopsy site and include hematoma, hemorrhage, infection, pain, and tissue adherence to the biopsy needle while removing it from the breast or axilla.
• CW027

  Use ultrasound guidance when you operate NeoNavia®, to visualize the movements of the device. Do not use MRI or stereotactic guidance. The NeoNavia® is MR unsafe.
• CW001

  Do not re-sterilize NeoNavia® biopsy probes. They are intended for single patient use only. The use of re-sterilized components, intended for single patient use only, can result in infection or injury of the patient.
• CW009

  Do not use NeoNavia® biopsy probes more than once. They are intended for single patient use only. If components that are intended for single patient use only are used again, it can result in infection or injury of the patient.
• CW007

  Do not use NeoNavia® biopsy probes if the sterile package is broken or damaged or if the Use by date has passed.
• CW032

  Do not use NeoNavia® biopsy probes if the sterile package is broken or damaged or if the Use by date has passed.
• CW008

  Use applicable personal protective equipment following local guidelines (for example gloves), during operation and maintenance of NeoNavia®, to prevent exposure to biohazards.
• CW999

  Follow instructions for use!

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

Dénomination commerciale

NeoNavia FlexiPulse probe

Code d'UDI-DI

17350081940079

Basic UDI-DI

735008194NEONAVIAPROBED2

Numéro de référence/catalogue

REF# 2104

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

https://neonavia.se/ifu

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

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

• A01020199NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER