Duns Number:175425982
Device Description: Personal Lubricant 4 fl. oz.
Catalog Number
53004
Brand Name
Blossom Organics
Version/Model Number
Natural
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
97c8c12f-95be-454d-ba7d-f26a85c59288
Public Version Date
December 06, 2021
Public Version Number
6
DI Record Publish Date
September 15, 2016
Package DI Number
20016169530047
Quantity per Package
6
Contains DI Package
00016169530043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SHRINK WRAP
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |