Dr. Scholl's

GUDID 10311017405328

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, 7 disposable applicators and information booklet.

BAYER HEALTHCARE LLC

Wart-removal cryogenic kit

• Primary Device ID: 10311017405328
• NIH Device Record Key: c7cae9be-2090-42c5-8ee0-8e91bde82970
• 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: 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00311017405321 [Primary]
GS1	10311017405328 [Package]; Contains: 00311017405321; Package: [12 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-07-20
• Device Publish Date: 2016-09-01