Cryo Professional

GUDID 08717484792841

Cryo Professional Aerosol Can

Koninklijke Utermöhlen N.V.

Cryogenic spray, cutaneous
Primary Device ID08717484792841
NIH Device Record Keybfce6fae-5c69-40c7-8838-c4ed64715716
Commercial Distribution StatusIn Commercial Distribution
Brand NameCryo Professional
Version Model NumberUTM0200
Company DUNS402035372
Company NameKoninklijke Utermöhlen N.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl
Phone+31561693366
Emailkwaliteit@utermohlen.nl

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store away from diathermy equipment, medical gases, and other types of incendiary sources.

Device Identifiers

Device Issuing AgencyDevice ID
GS108717484792841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-04
Device Publish Date2024-06-26

On-Brand Devices [Cryo Professional]

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

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