Surgify Halo

Organization name

Surgify Medical Oy

SRN

FI-MF-000017137

Manufacturer status

Active

13 warnings recorded — scroll inside the panel to see all entries.

• CW999

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

  Warnings: 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

  Warnings: 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 did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW999

  Warnings: Manually limit the electric motor speed to a maximum of 36000 RPM (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

  Warnings: 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

  Warnings: 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

  Warnings: 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

  Warnings: 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

  Warning: 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.

Primary placement in Finland; available across 8 countries total.

Trade name

Surgify Halo

UDI-DI code

06429830116912

Basic UDI-DI

64298301169SurgifyHaloSE

Reference / catalog number

100-54-TM

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5.4 MU50

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

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.