Duns Number:152793493
Device Description: Advanced Wart Freeze 8 applications
Catalog Number
-
Brand Name
Advanced Wart Freeze
Version/Model Number
017276237313
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 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
4cb9307f-5307-4082-bdaa-67429e413719
Public Version Date
July 23, 2021
Public Version Number
2
DI Record Publish Date
September 20, 2020
Package DI Number
10017276237310
Quantity per Package
6
Contains DI Package
00017276237313
Package Discontinue Date
April 26, 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 |