Duns Number:060272465
Device Description: COMPOUND W® DUAL POWER (2-in-1 Treatment Kit for Large Warts)
Catalog Number
N/A
Brand Name
Compound W®
Version/Model Number
CW067601; CW067201; CW067202; CW068101 (First Aid)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
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
K161294,K161294
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
bbf2776d-266a-41d6-bb3c-25f7cf9c8248
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 09, 2017
Package DI Number
10075137110851
Quantity per Package
12
Contains DI Package
00075137110854
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 14 |