PRES-5-40

Nom de l'organisation

phenox GmbH

SRN

DE-MF-000006524

Statut du fabricant

Actif

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

• CW010

  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.
• CW007

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

  For procedural cautions, consult IFU
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with pre-existing hemorrhage in the brain tissue supplied by the target vessel
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with established infarction in the brain tissue supplied by the target vessel
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with known sensitivity to nickel-titanium
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with stenosis and/or previously implanted stent proximal to the thrombus site that may preclude safe recovery of the device
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with tortuous intracranial vessels precluding safe retraction of the device
• CW265

  COBALT
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with angiographic evidence of carotid dissection
• CW999

  Contraindication: The use of a variant of the medical device group Thrombectomy Systems is contraindicated in patients with vessels with a diameter smaller than the lower limit as indicated in the IFU labeling

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

04260123784089

Basic UDI-DI

426012378ThrombectomyF6

Numéro de référence/catalogue

PRES-5-40

Entité d'attribution

GS1

Catégorie de risque

Classe III

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://phenox.net/international/mdr/ts

Dimensions cliniques

• Shaft diameter 5 mm; min. vessel diameter 2 mm
• usable length 45 mm

• C010402020702MECHANICAL PERIPHERAL THROMBECTOMY AND THROMBOASPIRATION SYSTEMS

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

Santé des certificats sur le portefeuille de ce fabricant.