07011759

Organization name

Oystershell NV

SRN

BE-MF-000011797

Manufacturer status

Active

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

• CW999

  "Do not treat the wart for longer than 15 sec on thin skin (hands, fingers, arms, toes, top/sides of feet) and 40 sec on callous, thick skin (soles of feet) i.e. plantar warts. Misuse or prolonged use can freeze the skin too deeply and cause damage to the skin, resulting in scars and/or nerve damage. The CARBONFREEZE pen should be used by an adult when treating warts on children. Do not touch the surface of the white ice tablet. This can result in freezing /burning/scarring of healthy tissue or blindness. Do NOT treat more than 1 wart per part of the body at one time. Any remaining wart can be treated separately with a 2-week interval between treatments. This minimizes any chance of “over freezing,” which can result in burns and permanent scarring of healthy tissue. Do NOT treat the same wart again within 2 weeks. Avoid contact with eyes. Contact with the eyes may cause blindness. Do not rub or touch the eyes if CARBONFREEZE has been applied to hands. For external use only. CO2 is an odourless, non-toxic, non-flammable gas. Use only as directed. Misuse of CARBONFREEZE may result in burns and permanent scarring of healthy tissue or blindness. Failure to follow instructions may result in serious injury or harm. Do not apply cosmetic, nor local medications on the wart treated. "
• CW164

  Only use in well-ventilated places.
• CW091

  Symptoms can include feeling dizzy or confusion and headache.
• CW158

  Do not inhale carbon dioxide. Breathing the contents is hazardous. Only use in well-ventilated places. Breathing the contents is hazardous – symptoms can include feeling dizzy or confusion and headache.
• CW416

  If product gets into the eyes, flush with water for 15 minutes and seek medical help immediately.
• CW311

  If product gets into the eyes, flush with water for 15 minutes and seek medical help immediately.
• CW268

  Pressurized container. May burst if heated. Do not pierce or burn even after use - the pen is under high pressure and cannot be opened.
• CW135

  Keep out of the sight and reach of children.
• CW011

  Precautions
• CW032

  Do not use the product after its expiry date as stated on the package.
• CW275

  "Do not use CARBONFREEZE if you are pregnant or breastfeeding*. *There is no clinical data on the use of CARBONFREEZE by pregnant or breastfeeding women."
• CW010

  "Please read the leaflet carefully before treatment. READ ALL INSTRUCTIONS CAREFULLY BEFORE USING CARBONFREEZE. "

Primary placement in Poland; available across 1 country total.

Trade name

not provided

UDI-DI code

05410765009654

Basic UDI-DI

5410765PixieCO2FQ

Reference / catalog number

07011759

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

No clinical sizes registered for this device.

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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