Duns Number:804085293
Device Description: Advanced Wart Freezer One-Step Wart Remover
Catalog Number
20464288
Brand Name
Core Values
Version/Model Number
20464288
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 08, 2018
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
abade7d1-5f5c-40e8-9cf5-7727af176ff2
Public Version Date
August 17, 2021
Public Version Number
4
DI Record Publish Date
June 16, 2017
Package DI Number
10017276232285
Quantity per Package
6
Contains DI Package
00017276232288
Package Discontinue Date
October 08, 2018
Package Status
Not in Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |