305200001

Organization name

COMEPA INDUSTRIES

SRN

FR-MF-000004169

Manufacturer status

Active

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

• CW011

  Do not cut or modify the plate. Do not reposition it once applied. Do not add gel. ▪ Avoid all contact between the active cable and the patient's skin. Avoid tangling the cable. ▪ Do not exceed 50W for newborn plates. ▪ Do not use the device if the packaging is damaged or if the expiration date has passed. ▪ Do not use the product if it has been exposed to environmental conditions beyond those specified. ▪ Do not apply the plate over trauma, scars, bony prominences, or in proximity to ECG electrodes. ▪ Do not position the plate over or near metallic implants (e.g., pacemakers or orthopedic prostheses). ▪ Ensure the entire surface of the electrode is properly attached to well-vascularized skin, close to the surgical site. ▪ Do not reuse the product. Reuse may lead to cross-contamination or device failure. ▪ If abnormal operation of the electrosurgical unit is detected (e.g. low output), check the application and connections before increasing power. ▪ The device is not intended for high-current modes. ▪ Stop the procedure if an alarm indicates poor contact or skin injury. ▪ Avoid skin-to-skin contact (e.g. underarms) by inserting dry gauze. ▪ Ensure monitoring and active cables do not contact each other or the patient. ▪ Store unused active electrodes away from the patient. ▪ Regularly inspect accessories and cables for damage.
• CW010

  The device is intended for use on intact skin only. ▪ Prepare the skin by shaving, cleaning and drying the area of application. ▪ Open the pouch and remove the protective film just before use. ▪ Follow the electrosurgical generator’s user manual. ▪ Inspect the cable and device integrity before application. ▪ Apply the electrode firmly from one edge to ensure good adhesion. ▪ Before placing surgical drapes, verify full contact between electrode and skin. ▪ After use, gently remove the electrode from an edge — never pull by the cable. ▪ In case of known allergies to any of the electrode components (see datasheet), do not use the device. ▪ Dispose of the used product in compliance with medical waste regulations. Used products may present microbial hazards.

Primary placement in France; available across 13 countries total.

Trade name

not provided

UDI-DI code

03663996011855

Basic UDI-DI

B-03663996011855

Reference / catalog number

305200001

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

PLACOM is disposable, non-sterile dispersive electrode with or without a pre-attached wire available in a comprehensive range of shapes and sizes (adult and paediatric).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• K02010201ELECTROSURGERY SINGLE PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE

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

This device is not currently linked to any other device.