12-1274

Nom de l'organisation

AprioMed AB

SRN

SE-MF-000001013

Statut du fabricant

Actif

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• CW027

  EUDAMED n'a pas publié de description pour ce code.
• CW011

  EUDAMED n'a pas publié de description pour ce code.
• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW007

  EUDAMED n'a pas publié de description pour ce code.
• CW009

  EUDAMED n'a pas publié de description pour ce code.
• CW001

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

  When using devices from other manufacturers, first check the compatibility (length and gauge) of the tool with the Bonopty® components.
• CW999

  Use finger force only during the biopsy procedure. Do not use extra tools to manipulate the the components of the Bonopty® System
• CW999

  The Penetration Cannula is designed for anchorage, and is not intended for passage through thick intact cortical bone.
• CW999

  Not suitable for very sclerotic or purely lytic lesions. If a target or trajectory proves to be too hard to sample or penetrate using the Bonopty® Biopsy Cannula, stop the procedure and remove the Cannula. It may be possible to sample using the Bonopty® Extended Drill instead
• CW999

  When the procedure is completed, do not remove the cannula without the support of the stylet or drill. Otherwise there is a risk that the cannula may break and part of it remains in the bone.
• CW999

  Bonopty is intended for use in image-guided procedures only. Verify the device location using imaging techniques after every device adjustment. Do not use Bonopty in Magnetic Resonance Imaging (MRI) equipment. The device is magnetic and exposure to MRI may cause unintended device movement.
• CW999

  Precaution 4: Be careful not to bend the components of the Bonopty® System during manipulation
• CW999

  Precaution 1: The Bonopty® Coaxial Bone Biopsy System with Eccentric Drill should be used only by or under the supervision of a physician trained in biopsy or radiological interventions.
• CW999

  Precaution 2: Carefully inspect the contents of the system prior to use to verify that all parts are present and undamaged
• CW999

  Precaution 3: The Bonopty® System is designed for single patient use only. After one use, components of the system may become dull or damaged, making a biopsy more difficult and less successful.
• CW999

  Precaution 5: Contaminated products should be disposed utilizing standard hospital procedures for biohazardous waste.
• CW999

  Precaution 6: During drilling, do not push the Cannula forward over the Drill, this hinder the ”wobbling” movement of the eccentric Drill and prevent the transportation of bone material out from the hole

Marché principal en Suède ; disponible dans 32 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

07350031350326

Basic UDI-DI

73500313511KG

Numéro de référence/catalogue

12-1274

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://apriomed.com/wp-content/uploads/29609.pdf

Dimensions cliniques

• 13
• 16.5 MU10

• 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.

• A0102010101SHEARING BIOPSY NEEDLES