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
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
9a686aed-5eda-4364-9376-2f05fecf7a3f
Public Version Date
July 12, 2018
Public Version Number
3
DI Record Publish Date
September 29, 2017
Package DI Number
10050428371050
Quantity per Package
6
Contains DI Package
00050428371053
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 | 82 |
2 | A medical device with a moderate to high risk that requires special controls. | 139 |
U | Unclassified | 23 |