07011677

Organization name

Oystershell NV

SRN

BE-MF-000011797

Manufacturer status

Active

14 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 NITROFREEZE pen should be used by an adult when treating warts on children. Do not touch the surface of the cooled applicator tip. This can result in freezing/burning/scarring of healthy tissue or blindness. Do NOT use applicator tips other than those supplied with the product. Always use the applicator tip supplied with the product when using NITROFREEZE. Use 1 applicator tip for each wart. Do NOT treat more than 1 wart per part of the body at one time. Any remaining warts 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 NITROFREEZE has been applied to hands. For external use only. Do not eat. Contents are toxic and may cause serious internal damage. If eaten by accident, get medical help or contact a poison control centre immediately. Use only as directed. Misuse of NITROFREEZE 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."
• CW010

  "Instructions for use: Read information insert (inside box) carefully for all instructions and additional precautions and contra-indications before using NITROFREEZE. READ ALL INSTRUCTIONS CAREFULLY BEFORE USING NITROFREEZE. "
• CW011

  Precautions
• CW032

  Do not use the product after the expiry date as stated on the package.
• CW135

  Keep out of the sight and reach of children. Contains small parts.
• CW068

  Nitrous oxide is a non-toxic, non-flammable gas, but it will support combustion in case of fire. Keep away from heat/sparks/open flames/hot surfaces. Do not smoke or use near a naked flame.
• 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.
• CW158

  Do not inhale nitrous oxide. 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.
• CW164

  Only use in well-ventilated places.
• CW091

  symptoms can include feeling dizzy or confusion and headache.
• CW275

  "Do not use NITROFREEZE if you are pregnant or breastfeeding*. *There is no clinical data on the use of NITROFREEZE by pregnant or breastfeeding women"
• 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.
• CW009

  Do not reuse the applicator tip.

Primary placement in Sweden; available across 1 country total.

Trade name

not provided

UDI-DI code

05410765008411

Basic UDI-DI

5410765PixieN2OGK

Reference / catalog number

07011677

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