Duns Number:001211952
Catalog Number
-
Brand Name
TROJAN LUBRICANT CHAIN REACTION SAMPLE 2ML
Version/Model Number
00022600998471
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
K161544
Product Code
NUC
Product Code Name
Lubricant, personal
Public Device Record Key
15ed4b54-fea8-4dad-916d-5940a57a42ea
Public Version Date
August 07, 2020
Public Version Number
5
DI Record Publish Date
December 21, 2016
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 |