Duns Number:152793493
Device Description: Advanced Wart Freeze 1-Step Wart Remover
Catalog Number
B07D1CVLV3
Brand Name
ALL-HEALTH
Version/Model Number
B07D1CVLV3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2021
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
b7900164-4419-463b-9082-c362e23fdc8e
Public Version Date
July 23, 2021
Public Version Number
2
DI Record Publish Date
September 10, 2018
Package DI Number
20017276233777
Quantity per Package
6
Contains DI Package
00017276233773
Package Discontinue Date
June 22, 2021
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 | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |