Duns Number:060272465
Device Description: Accu-Freeze® Freeze Off® Advanced Wart Removal System
Catalog Number
-
Brand Name
Compound W®
Version/Model Number
CW044201, CW044104, CW044601
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
K140314,K140314,K140314
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
77d035c2-7d76-4987-86ac-25d0f2b726e6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
20075137108251
Quantity per Package
6
Contains DI Package
00075137108257
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner pack DI
| 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 |