Dr Scholls Freeze Away Dual Action 90000120

GUDID 00888853001333

Cryogenic Wart Remover

SCHOLL'S WELLNESS COMPANY LLC

Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit Wart-removal cryogenic kit

• Primary Device ID: 00888853001333
• NIH Device Record Key: ba99142b-ee57-4024-b531-be4394d8e358
• Commercial Distribution Discontinuation: 2021-09-03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr Scholls Freeze Away Dual Action
• Version Model Number: 7ct Blue
• Catalog Number: 90000120
• Company DUNS: 117174744
• Company Name: SCHOLL'S WELLNESS COMPANY 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com
• Phone: 973-801-5515
• Email: alex.terranova@drscholls.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888853001333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031697

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-11
• Device Publish Date: 2020-09-03