Duns Number:001211952
Catalog Number
-
Brand Name
Trojan Magnum Personal Lubricant
Version/Model Number
00022600000204
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
K180764
Product Code
NUC
Product Code Name
Lubricant, personal
Public Device Record Key
1988ee22-490f-4d2e-8df6-3a135f92cd0c
Public Version Date
August 07, 2020
Public Version Number
2
DI Record Publish Date
February 20, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 80 |
U | Unclassified | 2 |