Duns Number:879057065
Catalog Number
-
Brand Name
SportLube
Version/Model Number
SportLube 3.4 fl oz Silicone Based
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
084a392f-5e3c-4877-a10a-d01535180037
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
March 06, 2018
Package DI Number
40865542000349
Quantity per Package
24
Contains DI Package
00865542000341
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 56 |