Duns Number:153909531
Catalog Number
700150
Brand Name
Liquid Lubricant
Version/Model Number
1.69oz
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
K211998,K211998
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
48719aa8-3d7a-4ed4-8ae4-c96742ffd2df
Public Version Date
April 22, 2022
Public Version Number
1
DI Record Publish Date
April 14, 2022
Package DI Number
30850014621545
Quantity per Package
24
Contains DI Package
00850014621544
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 9 |