CCN19G-12

Nom de l'organisation

AprioMed AB

SRN

SE-MF-000001013

Statut du fabricant

Actif

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

• CW999

  Contraindication: Not intended for use in the bone.
• CW999

  Good medical judgement should be exercised in considering biopsy on patients who are receiving anticoagulant therapy or who have bleeding disorders. Use in these patient populations may result in severe bleeding
• 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

  Do not use excessive force against resistance. If the needle is damaged or bent, do not use. Retract the bent part simultaneously with the rest of the device to prevent needle breakage and materials remaining in the body.
• CW999

  Precaution 2: Before use together with other equipment, check the compatibility in length and gauge together with Corbo Coaxial® Needle
• CW999

  Precaution 3: Before use, inspect the device for damaged needle point, bent shaft or other imperfections that would prevent proper function. If the needle components are damaged or bent or do not move together easily, do not use.
• CW999

  Precaution 4: Administration of local anesthesia must be conducted by, or under supervision of physician with experience of regional anesthesia in accordance with the drug and syringe manufacturer instructions.
• CW999

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

  One potential complication of coaxial image-guided biopsy is inadvertent perforation of adjacent structures. Inadvertent perforation may result in site specific complications which may consist of bleeding, including bleeding from the large artery, hematoma, hemorrhage, infection, pain, cardiac tamponade, pneumothorax, hemoptysis and hemothorax.
• CW999

  Precaution 1: Corbo Coaxial® Needle must be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of core needle biopsy, in particular, those relating to the specific organ being biopsied
• CW999

  Precaution 5: After use, the components may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

07350031350609

Basic UDI-DI

73500313519KY

Numéro de référence/catalogue

CCN19G-12

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/29594.pdf

Dimensions cliniques

• 12 MU10
• 19

• 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