Freeze Away Dual Action Wart Remover

Basic Information

• Brand Name: Freeze Away Dual Action Wart Remover
• Primary DI: 10888853001330
• Version / Model: 90000336
• Company Name: SCHOLL'S WELLNESS COMPANY LLC
• Labeler DUNS: 117174744
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 8
• Record Status: Published
• Publish Date: 2025-01-23
• Public Version: 1
• Public Version Date: 2025-01-31
• Public Version Status: New
• Public Device Record Key: 09f1f048-6421-4440-8fb3-ad0bb30b6930

Device Description

Cryogenic wart remover kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	878.4350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42518	Wart-removal cryogenic kit	A collection of devices designed to apply cold from a liquid/gaseous refrigerant (cryogen) to a common or plantar (sole of foot) wart for its removal. The collection typically includes a pressurized cannister with a cryogenic mixture (e.g., liquid dimethyl ether and propane), disposable applicators, a reusable activator that releases the cryogen into the applicators, and cushions; it may also include a liquid wart remover (e.g., salicylic acid) for post-cryo treatment. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00888853001333	GS1
Primary	10888853001330	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K052259	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit