Duns Number:006959555
Device Description: Wart Freezer Cryogenic Treatment 1-Step Wart Remover
Catalog Number
4080389
Brand Name
Meijer
Version/Model Number
4080389
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
88e420ba-b556-4dfb-ae54-9b8b2b33d1ee
Public Version Date
September 24, 2018
Public Version Number
5
DI Record Publish Date
March 31, 2017
Package DI Number
10713733086148
Quantity per Package
6
Contains DI Package
00713733086141
Package Discontinue Date
September 24, 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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |