Duns Number:112117283
Device Description: Dr. Scholl's Dual Action Freeze Away Wart Remover provides convenient home use treatment f Dr. Scholl's Dual Action Freeze Away Wart Remover provides convenient home use treatment for noncancerous, yet contagious plantar and common warts. It is a combination of freezing and liquid ( acid) treatment of the wart. It 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, 9.8ml liquid wart remover, 9 cover- up cushions, and information booklet.
Catalog Number
-
Brand Name
Dr. Scholl's
Version/Model Number
1612171
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K052259,K052259
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
23889ea5-3d5e-48d3-b77e-63a47368f191
Public Version Date
October 01, 2020
Public Version Number
6
DI Record Publish Date
September 01, 2016
Package DI Number
10311017405304
Quantity per Package
12
Contains DI Package
00311017405307
Package Discontinue Date
October 01, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |