Duns Number:022200656
Device Description: Unscented Personal Lubricant made with 96% Organic ingredients.
Catalog Number
100UNSCNT22
Brand Name
Sustain
Version/Model Number
Sustain Unscented Personal Lubricant 2.5 oz
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
Yes
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
-
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
ff322cd5-0af0-4545-85c1-a7e7eb5d1ca0
Public Version Date
August 07, 2020
Public Version Number
6
DI Record Publish Date
October 09, 2017
Package DI Number
10856078005181
Quantity per Package
6
Contains DI Package
00856078005184
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
inner carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |