Verruca-Freeze H

GUDID 00860001513721

Verruca-Freeze H Single Kit with Round Applicators

CryoSurgery, Inc.

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00860001513721
• NIH Device Record Key: 0a526c3d-0691-4ab4-8c92-9d16af6dbb2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verruca-Freeze H
• Version Model Number: VFH1R
• Company DUNS: 793483256
• Company Name: CryoSurgery, Inc.
• 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: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and direct heat sources.
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001513721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243454

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: 2025-05-06
• Device Publish Date: 2025-04-28

On-Brand Devices [Verruca-Freeze H]

• 00860001513738: Verruca-Freeze H Double Kit with Mixed Applicators
• 00860001513721: Verruca-Freeze H Single Kit with Round Applicators
• 00860001513714: Verruca-Freeze H Single Kit with Arrow Applicators
• 00860001513707: Verruca-Freeze H Single Kit with Mixed Applicators