Duns Number:062312574
Device Description: Ready to Use Wart Freezer Cryogenic Treatment
Catalog Number
717272
Brand Name
CVS Health
Version/Model Number
717272
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 07, 2016
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
263b09e3-f5ba-4f8f-8abb-7080a8663174
Public Version Date
July 12, 2018
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
10050428542634
Quantity per Package
6
Contains DI Package
00050428542637
Package Discontinue Date
October 07, 2016
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |