Duns Number:364614362
Device Description: 1 Bottle of Silicone Personal Lubricant
Catalog Number
-
Brand Name
ONE MOVE
Version/Model Number
11L201
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
25301a3e-c1e4-4dcd-9b5a-b05b7fa3af00
Public Version Date
August 07, 2020
Public Version Number
2
DI Record Publish Date
June 01, 2020
Package DI Number
10726893210049
Quantity per Package
3
Contains DI Package
00726893210042
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
bundle of 3 bottles
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 152 |