Histofreezer FLEX 80SM

GUDID 00850077006371

Histofreezer FLEX Kit 80SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.

CRYOCONCEPTS, LP

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00850077006371
• NIH Device Record Key: a2e11512-4f75-433c-8061-6c41b79dcd4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histofreezer FLEX
• Version Model Number: 200-6080
• Catalog Number: 80SM
• Company DUNS: 038024868
• Company Name: CRYOCONCEPTS, LP
• 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: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com
• Phone: 1-855-355-2796
• Email: support@cryoconcepts.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850077006371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183601

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: 2020-09-21
• Device Publish Date: 2020-09-13

On-Brand Devices [Histofreezer FLEX]

• 00850077006371: Histofreezer FLEX Kit 80SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical
• 00850077006401: Histofreezer FLEX Kit 50SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical d
• 00850077006395: Histofreezer FLEX Kit 50SC Small Cone Kit. The Histofreezer FLEX is intended for the surgical d
• 00850077006388: Histofreezer FLEX Kit 50SB Small Bud Kit. The Histofreezer FLEX is intended for the surgical de