Cryo Professional

GUDID 08717484790502

Cryo Professional 60x5mm Applicators (6-Kit Case) Each individual kit (GTIN 08717484790496) contains: 2 Aerosol Cans (GTIN: 08717484792841) and 1 Applicator box (GTIN: 08717484792827)

Koninklijke Utermöhlen N.V.

Cryogenic spray, cutaneous

• Primary Device ID: 08717484790502
• NIH Device Record Key: cb3063ef-bfb2-4faa-840a-cdebf6f7e698
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cryo Professional
• Version Model Number: UTM0300
• Company DUNS: 402035372
• Company Name: Koninklijke Utermöhlen N.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl
• Phone: +31561693366
• Email: kwaliteit@utermohlen.nl

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717484790502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152203

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-04
• Device Publish Date: 2024-06-26

On-Brand Devices [Cryo Professional]

• 08717484792841: Cryo Professional Aerosol Can
• 08717484792834: Cryo Professional Applicator (30x2mm, 30x5mm)
• 08717484792827: Cryo Professional Applicator 60x2mm
• 08717484792810: Cryo Professional Applicator 50x5mm
• 08717484792780: Cryo Professional Mixed (30x5mm, 30x2mm) Applicator with Aerosol Kit Each individual kit contain
• 08717484790540: Cryo Professional 50x5mm Applicators (6-Kit Case) Each individual kit (GTIN 08717484790533) cont
• 08717484790533: Cryo Professional 50x5mm Applicator with Aerosol Kit Each individual kit contains: 2 Aerosol Can
• 08717484790526: Cryo Professional Mixed (30x5mm, 30x2mm) Applicators (6-Kit Case) Each individual kit (GTIN 0871
• 08717484790502: Cryo Professional 60x5mm Applicators (6-Kit Case) Each individual kit (GTIN 08717484790496) cont
• 08717484790496: Cryo Professional 60x2mm Applicator with Aerosol Kit Each individual kit contains: 2 Aerosol Can