Organization name

Integra LifeSciences Switzerland SARL

SRN

CH-MF-000009386

Manufacturer status

Active

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

• Do not activate the forceps connected to the cord and tubing set when not in contact with target tissue, as this may cause injuries due to capacitive coupling with other surgical equipment.

  OTHER

• Do not exceed 500 Volts peak to peak in COAG mode. Failure to observe mode and setting warnings may reduce efficacy of non-stick performance, result in unintended burns, and/or cause failure of device insulations.

  OTHER

• Do not place active forceps and cord and tubing set near or in contact with flammable materials such as gauze or surgical drapes. Instruments that are activated or hot from use may cause a fire.

  OTHER

• Do not place the instruments directly on or near the patient when not in use. Place the active forceps and cord and tubing set on a visible, non-conductive area away from the patient or in a non-conductive instrument holster when not in use. Inadvertent contact with the patient may cause burns.

  OTHER

• Do not use in patients who have cardiac pacemakers or other active implants without first consulting a qualified professional (e.g., cardiologist). A possible hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged.

  OTHER

• Do not use in the presence of flammable anesthetics or oxidizing gases or in close proximity to volatile solvents, as explosion may occur.

  OTHER

• Observe all additional warnings provided with the bipolar electrosurgical generator.

  OTHER

• Ensure the bipolar electrosurgical generator is in the "off" position when connecting the cord and tubing set. Failure to observe warning may result in electrical shock or injury to the patient or operating room personnel.

  OTHER

• Failure to follow these warnings could result in fire or patient injury.

  OTHER

• Inspect instruments for damage prior to use. This may be done visually under magnification or with a high voltage insulation testing device. Insulation failures may result in burns or other injuries to the patient or operator.

  OTHER

• Position electrosurgical cords to avoid contact with patient or other leads.

  OTHER

• Select the minimum COAG output power possible to achieve coagulation.

  OTHER

• The surface of the active electrode may remain hot enough to cause burns after the RF current is deactivated.

  OTHER

• This product contains a chemical (DEHP) known to the State of California to cause cancer, or birth defects, or other reproductive harm.

  OTHER

Primary placement in Belgium; available across 23 countries total.

Trade name

CODMAN®

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

10381780521747

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-10381780521747

Reference / catalog number

9190001RP

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Codman Integrated Bipolar Cord and Tubing Set, 10/Box, Sterile Fixed leads Rotary pump

Additional information URL

https://labeling.integralife.com/

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• A03040299IRRIGATION KITS, SINGLE-USE - OTHER

• Class IIa medical devices in EUDAMED

This device is not currently linked to any other device.

No certificate specifically references this device's Basic UDI-DI.