Duns Number:006959555
Device Description: Personal LubricantNET WT 4 OZ (113 g)
Catalog Number
-
Brand Name
Meijer Personal Lubricant
Version/Model Number
7W9266EC1
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
K012203,K180923,K012203,K180923
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
66dedf80-ddd1-47e2-824b-df8d1eef0567
Public Version Date
August 11, 2020
Public Version Number
1
DI Record Publish Date
August 03, 2020
Package DI Number
10719283168341
Quantity per Package
72
Contains DI Package
00719283168344
Package Discontinue Date
-
Package Status
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 | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 45 |
U | Unclassified | 1 |