P1-AU411

Organization name

SpineGuard.S.A

SRN

FR-MF-000004720

Manufacturer status

Active

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

• CW999

  Do not use the device: - In the presence of flammable anesthetics - At room temperature above 30°C - In a humid environment. • Use of the PediGuard in conditions of extreme osteoporosis is not recommended. The condition of the bone in this situation must be closely evaluated prior to use of the device. • Only use components provided by SpineGuard. Using components from another manufacturer may cause malfunction of the device and be harmful to the patient. • No modification of this equipment is allowed. • Patient positioning on the operating table is critical: ensure that leg motions (if any) will not cause any injury to the patient or a fall from the operating table. • Avoid any contact between the PediGuard and the patient while using an electrocautery device or defibrillator. • Use of the device near the thorax may increase the risk of cardiac fibrillation. • Using the PediGuard in association with another electronic device requires special precautions: perturbations on the patient’s ECG monitor may be observed while the PediGuard is in use. These abnormalities will stop as soon as the instrument is removed. • IMPORTANT: Do not allow fluids or foreign bodies in the handle (immersion of the handle, even for a short period of time, is prohibited). In case of fluids or foreign bodies ingress in the electronics casing, do not use the device.
• CW999

  Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. • Portable RF communications equipment (including peripherals such as antenna cables and externals antennas) should be used no closer than 30 cm (12 inches) to any part of the PediGuard System. Otherwise degradation of the performance of this equipment could result. • Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy ME equipment may produce instability in the device output.

Primary placement in France; available across 14 countries total.

Trade name

not provided

UDI-DI code

03662674000006

Basic UDI-DI

3662674P1AUXXXYJ

Reference / catalog number

P1-AU411

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

PediGuard® Gearshift is a pedicle preparation device that helps surgeons to drill a pilot hole through the pedicle of the vertebrae during spinal surgery. It serves to alert the surgeons prior to a possible cortex perforation while drilling through the pedicle, by accurately analyzing the electrical conductivity of the surrounding tissues

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12130503ORTHOPAEDIC SURGICAL DRILLS

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

Certificate health across this manufacturer's portfolio.