Needle #1

Organization name

SpineGuard.S.A

SRN

FR-MF-000004720

Manufacturer status

Active

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

• CW999

  The contraindications are: -Pathologies involving the vertebral cortex -Patients who have received a pacemaker or any other active medical device. -The Cannulated PediGuard should not be used in direct contact with the central nervous system. -The contact with any part of the dura mater, may it be the part sheathing the medulla spinalis or the part sheathing the roots of the nerves up to the spinal ganglia, shall be avoided.
• 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.
• CW009

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

  No modification of this equipment is allowed. •Intraoperative use of muscle relaxants inhibits muscular contractions which are normally used as a means of detection. Use of muscle relaxants is therefore discouraged when using the PediGuard System. •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. •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.
• CW010

  EUDAMED did not publish a description for this code.
• CW001

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

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 11 countries total.

Trade name

Needle #1

UDI-DI code

03662674000075

Basic UDI-DI

B-03662674000075

Reference / catalog number

P2ND1001

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The Needle (part 2) is intended to be assembled with the electronic handle (part 1) and to drill the bone. It is made of a cannula and a detachable inner stylet that has a trocar tip that also contains the sensor for electrical conductivity measurement.

Additional information URL

https://www.spineguard.com/products-and-applications/spine-products/user-manuals/cpg-brochure/

Clinical sizes

No clinical sizes registered for this device.

• Z12139099VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER

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• Expiration date
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• Serial number
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Certificate health across this manufacturer's portfolio.