Dr. Scholl's

Basic Information

• Brand Name: Dr. Scholl's
• Primary DI: 00011017576983
• Version / Model: 1612171
• Company Name: BAYER HEALTHCARE LLC
• Labeler DUNS: 112117283
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-12
• Public Version: 5
• Public Version Date: 2020-10-01
• Public Version Status: Update
• Public Device Record Key: 1f2b3e54-b437-41a3-a23d-4a25ea828044
• Distribution End Date: 2020-10-01

Device Description

Dr. Scholl's Freeze Away Wart Remover ( blue Box) is a cryosurgical system for the removal of common and plantar warts. The device consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 12 disposable applicators and information booklet.

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: No
• 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	00011017576983	GS1
Package	10011017576980	GS1		12	Not in Commercial Distribution	2020-10-01

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius