Aurega Skin Barrier Spray

Organization name

Cortmed International Limited

SRN

IE-MF-000002464

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW038

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

  For external use only. Use only on intact skin. Single-use device - reuse of the device can compromise its safety, performance and effectiveness. Reprocessing, washing, disinfection or sterilization may compromise the product, posing a risk of irritation or injury. If irritation or an allergic reaction occurs, discontinue use of the device and contact a healthcare professional.

Primary placement in Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Trade name

Aurega Skin Barrier Spray

UDI-DI code

05391543842451

Basic UDI-DI

539154384SBSNV

Reference / catalog number

SBS50

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

The product is intended to form a barrier film which protects the skin in the event of contact with urine or feces, as well as from the mechanical damage associated with frequent removal of ostomy adhesives.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 50 MU03

• A108004PROTECTIVE FILMS / SPRAYS FOR PERISTOMAL SKIN

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