Dr Scholls Freeze Away Dual Action 7ct Blue

GUDID 00888853000084

Combination 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 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 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	00888853000084
NIH Device Record Key	6e32ac16-1082-4a73-8310-9691fe3aceff
Commercial Distribution Discontinuation	2023-01-01
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dr Scholls Freeze Away Dual Action 7ct Blue
Version Model 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	false
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	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
Email	alex.terranova@drscholls.com
Phone	19738015515
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
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
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	00888853000084 [Primary]
GS1	10888853000081 [Package] Package: Case [12 Units] Discontinued: 2021-01-07 Not in Commercial Distribution

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	2021-01-14
Device Publish Date	2021-01-06