Duns Number:060272465
Device Description: Original Cryogenic Wart Removal System - replaces DI 0037513783005
Catalog Number
-
Brand Name
Wartner®
Version/Model Number
WPUS001101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 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
-
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
9c06ec67-08a3-4d8f-ad2b-bebf28c0dc2f
Public Version Date
August 28, 2020
Public Version Number
3
DI Record Publish Date
January 13, 2020
Package DI Number
10075137000152
Quantity per Package
24
Contains DI Package
00075137000155
Package Discontinue Date
August 28, 2020
Package Status
Not 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 |