FP0054

Organization name

PS Product Services GmbH

SRN

DE-MF-000005290

Manufacturer status

Active

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

• CW162

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

  If you suffer from diabetes or from circulatory or skin disorders, use the product only after consulting your doctor.
• CW999

  - Keep the product and packaging materials out of the reach of infants. There is a risk of suffocation! - If you experience redness, inflammation or persistent discomfort when wearing the product, remove it immediately. It must not restrict the flow of blood. The product must not be worn while asleep or by anyone who is unable to indicate discomfort. - Only use the product on unbroken, healthy skin. The skin must be free of oils, creams, ointments, etc. - Serious incidents which occur while wearing the product must be reported to the manufacturer and the relevant authorities.

Primary placement in Germany; available across 5 countries total.

Trade name

not provided

UDI-DI code

04050235005260

Basic UDI-DI

4050235PS0004BG

Reference / catalog number

FP0054

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Toe spreaders

Additional information URL

https://www.product-services.de/gebrauchsanweisungen/

Clinical sizes

No clinical sizes registered for this device.

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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