Dr Scholls Freeze Away Max Wart Remover

Basic Information

• Brand Name: Dr Scholls Freeze Away Max Wart Remover
• Primary DI: 00888853000619
• Version / Model: 90000067
• Company Name: SCHOLL'S WELLNESS COMPANY LLC
• Labeler DUNS: 117174744
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-03
• Public Version: 4
• Public Version Date: 2023-03-10
• Public Version Status: Update
• Public Device Record Key: 0836f1ba-39f4-4e58-970b-7dfdcd92e1e8
• Distribution End Date: 2027-03-31

Device Description

A cryogenic aerosol wart remover

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• 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
Primary	00888853000619	GS1
Package	10888853000616	GS1	Case	12	Not in Commercial Distribution	2023-03-03

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K201366	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 120 Degrees Fahrenheit