Duns Number:008965063
Device Description: Freeze Wart Remover
Catalog Number
930448
Brand Name
Well at Walgreens
Version/Model Number
930448
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
-
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
3da34e1e-0ff2-4dd0-a6f5-10fc1d225cf4
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
August 15, 2016
Package DI Number
10311917182213
Quantity per Package
6
Contains DI Package
00311917182216
Package Discontinue Date
-
Package Status
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 | 75 |
2 | A medical device with a moderate to high risk that requires special controls. | 74 |
U | Unclassified | 2 |