SG13-171

Nom de l'organisation

AprioMed AB

SRN

SE-MF-000001013

Statut du fabricant

Actif

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

• CW999

  In case of bending of any part of the coaxial system, stop the procedure and retract the bent part simultaneously with the rest of the device. Removing bent parts only may cause breakage and result in materials remaining in the body.
• CW999

  Precaution 1: Before use together with other equipment, check the compatibility in length and gauge together with Gangi SoftGuard® using the reference guide included in the package.
• CW999

  Precaution 3: 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
• CW999

  Contraindication: Not intended for use in bone
• CW999

  Precaution 2: Before use, inspect the device for damaged 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: Gangi SoftGuard® 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

  Gangi-SoftGuard® is intended for use in image-guided procedures only. Verify the device location using imaging techniques after every device adjustment. Do not use Gangi-SoftGuard® 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
• 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

  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.

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

07350031350364

Basic UDI-DI

73500313512KJ

Numéro de référence/catalogue

SG13-171

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/29604.pdf

Dimensions cliniques

• 17.1 MU10
• 13

• 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