Duns Number:008965063
Device Description: 4oz (113g) Personal Lubricating Jelly
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
0F226
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 26, 2018
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
K012203,K012203
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
fc30428a-a9d7-4873-ab6c-0cf0e1f651e5
Public Version Date
January 30, 2020
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
10311917205059
Quantity per Package
72
Contains DI Package
00311917205052
Package Discontinue Date
October 26, 2018
Package Status
Not in Commercial Distribution
Package Type
Shipper
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 |