Surgify Halo

Nom de l'organisation

Surgify Medical Oy

SRN

FI-MF-000017137

Statut du fabricant

Actif

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

• CW999

  Device must be used in combination with sufficient irrigation.Use of sufficient irrigation is needed to avoid localized heating.
• CW999

  Ensure that the device is used with a compatible electric motor and handpiece (attachment). Using an incompatible electric motor and/or handpiece (attachment) may lead to severe accidents. For example, a burr that is too long may lead to shaft bending and device breakage.
• CW999

  Eye protection and surgical mask must be worn by operating staff while using the device. Use of the device may eject particles that may lead to harm. Personal protective equipment should be worn when using the device.
• CW010

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

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

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

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

  Manually limit the electric motor speed to a maximum of 36000 RMP (depending on the drill system, as shown in Table 1). Using the device at a higher RPM may lead to device breakage and severe injury to the patient and/or operating staff.
• CW999

  Device usage shall not exceed a total of 5 minutes or bone removal of 3.5 cm^3. Using the device for more than the indicated time and bone removal volume may lead to device breakage and severe injury to the patient and/or operating staff.
• CW999

  Do not apply excessive force to the device or operative surface. Using excessive force may lead to device damage and injury to the patient. Moreover, excessive force can also lead to excessive heat generation, leading to bone necrosis.
• CW999

  Do not intentionally touch soft tissue with the device. Effectiveness of the device depends on the correct and careful use. Improper use of the device may not provide the intended soft tissue protection during operation.
• CW999

  Do not touch the device with surfaces harder than bone, e.g., suction tubes, implants, etc. Touching metallic parts such as suction tubes, implants, or other surgical instruments may break or damage the device.
• CW999

  Do not reuse or resterilize the device. The device is for single use only - reusing or resterilizing the device may expose patients and users to biological contaminants and may lead to device breakage.

Marché principal en Finlande ; disponible dans 8 pays au total.

Dénomination commerciale

Surgify Halo

Code d'UDI-DI

06429830116967

Basic UDI-DI

64298301169SurgifyHaloSE

Numéro de référence/catalogue

100-54-SE

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

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 5.4 MU50

• V901699SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER

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

Santé des certificats sur le portefeuille de ce fabricant.