Dr. Scholl's

GUDID 10311017405304

Dr. Scholl's Dual Action Freeze Away Wart Remover provides convenient home use treatment for noncancerous, yet contagious plantar and common warts. It is a combination of freezing and liquid ( acid) treatment of the wart. It consists of the following: pressurized canister filled with liquid mixture of dimethyl ether and propane, reusable activator that releases the cryogen into the applicator, 7 disposable applicators, 9.8ml liquid wart remover, 9 cover- up cushions, and information booklet.

BAYER HEALTHCARE LLC

Wart-removal cryogenic kit

• Primary Device ID: 10311017405304
• NIH Device Record Key: 23889ea5-3d5e-48d3-b77e-63a47368f191
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr. Scholl's
• Version Model Number: 1612171
• Company DUNS: 112117283
• Company Name: BAYER HEALTHCARE LLC
• 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: true
• Single Use: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com
• Phone: 1-866-360-3226
• Email: cc-consreldept@bayer.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00311017405307 [Primary]
GS1	10311017405304 [Package]; Contains: 00311017405307; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052259

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-04
• Device Publish Date: 2016-09-01