SYYLEND FREEZE

Trade name

SYYLEND FREEZE

05410765008343

5410765PixieN2OGK

Reference / catalog number

07011670

GS1

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.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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

• 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.
• 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."