Dr Scholls Freeze Away Dual Action 90000120

GUDID 00888853001333

Cryogenic Wart Remover

SCHOLL'S WELLNESS COMPANY LLC

Wart-removal cryogenic kit
Primary Device ID00888853001333
NIH Device Record Keyba99142b-ee57-4024-b531-be4394d8e358
Commercial Distribution Discontinuation2021-09-03
Commercial Distribution StatusIn Commercial Distribution
Brand NameDr Scholls Freeze Away Dual Action
Version Model Number7ct Blue
Catalog Number90000120
Company DUNS117174744
Company NameSCHOLL'S WELLNESS COMPANY LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone973-801-5515
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com
Phone18623281407
Emailalex.terranova@drscholls.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100888853001333 [Primary]
GS110888853001330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-11
Device Publish Date2020-09-03