50611

Organization name

Laboratoires PAUL HARTMANN S.à.r.l

SRN

FR-MF-000004029

Manufacturer status

Active

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

• CW009

  EUDAMED did not publish a description for this code.
• CW011

  For patients with diabetes and/or who are in pain, limit debridement to dead tissue and avoid making the patient bleed. Avoid or limit wound debridement on following cases: - wound with adherent tissue that prevents a clear distinction between viable and non-viable tissue - wound too large - on high-risk sites (face, ear) - on patients in particular medical conditions especially patients with increased risk of bleeding (as patients under anticoagulation medication), with peripheral arterial disease, under severe malnutrition or with high-risk lesions (as malignant wounds, cutaneous malignancies). It is the responsibility of the healthcare professional to evaluate if the patient state is compatible with wound debridement. Notice to the user and patient: Please report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. In the absence of available data supporting the use on infants and children, the curette is not intended for pediatric use.

Primary placement in France; available across 2 countries total.

Trade name

not provided

UDI-DI code

03261480004798

Basic UDI-DI

32614834064W

Reference / catalog number

50611

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

• Diameter of the ring: 7 mm

• V0199CUTTING DEVICES, SINGLE-USE - OTHER

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