Duns Number:060272465
Device Description: COMPOUND W® COMPLETE WART KIT Maximum Freeze Plantar and Stubborn Warts
Catalog Number
N/A
Brand Name
Compound W®
Version/Model Number
CW066101; CW066601; CW066201; CW066501
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151309,K151309,K151309
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
4f18e3fb-d489-43c4-b1eb-84b726b13df0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 09, 2017
Package DI Number
20075137110575
Quantity per Package
6
Contains DI Package
00075137110571
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner pack
| 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 |