Duns Number:112117283
Device Description: Dr. Scholl's Freeze Away Wart Remover ( Yellow Box) is a cryosurgical system for the remov Dr. Scholl's Freeze Away Wart Remover ( Yellow 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.
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
722c6deb-bd6f-4b60-9197-a2be00c33fd8
Public Version Date
October 01, 2020
Public Version Number
5
DI Record Publish Date
September 01, 2016
Package DI Number
10311017405342
Quantity per Package
12
Contains DI Package
00311017405345
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 |