Cryo Proffesional

Organization name

Koninklijke Utermöhlen N.V.

SRN

NL-MF-000004873

Manufacturer status

Active

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

• CW010

  Read instruction for use carefully prior to using this product. Use of the product in accordance with its instructions at all time. Using the product in a way other than instructed, may lead to thermal reactions, skin damage, nerve damage and scar formation.
• CW054

  Extremely flammable aerosol
• CW140

  Do not spray onto an open flame or other ignition source.
• CW157

  Pressurized container: May burst if heated

Primary placement in Netherlands; available across 4 countries total.

Trade name

Cryo Proffesional

UDI-DI code

D-08717TD03-UTM0169WYY8

Basic UDI-DI

B-08717TD03-UTM0169WYY8

Reference / catalog number

UTM0169

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The Cryo Professional product is a portable cryosurgery unit comprised of a dispenser filled with dimethyl ether (DME)/bespoke hydrocarbon blend, fixed cap/applicator and a box of disposable foam-sticks in 2 sizes (2mm and 5mm tip). There are 2 sizes of dispensers, a 170ml and a 80 ml.

Additional information URL

https://www.utermohlenprofessional.com/cryo-professional

Clinical sizes

• 170 MU03

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

D-08717TD03-UTM0169WYY8

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• Z120102CRYOSURGERY EQUIPMENT