Duns Number:062312574
Device Description: CVS PERSONAL LUBRICATING JELLY 2OZ (CVS-024-2OZ)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
457518
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
K070623,K070623
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
0facb895-4ea2-4b17-907d-e9b3bb2531db
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
00504281274698
Quantity per Package
24
Contains DI Package
00050428127469
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 |