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 ID10311017405328
NIH Device Record Keyc7cae9be-2090-42c5-8ee0-8e91bde82970
Commercial Distribution StatusIn Commercial Distribution
Brand NameDr. Scholl's
Version Model Number1612171
Company DUNS112117283
Company NameBAYER HEALTHCARE 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 Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com
Phone1-866-360-3226
Emailcc-consreldept@bayer.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100311017405321 [Primary]
GS110311017405328 [Package]
Contains: 00311017405321
Package: [12 Units]
In Commercial Distribution

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-20
Device Publish Date2016-09-01