Duns Number:113170088
Device Description: Luer Loc Tips are used to dispense adhesive from a luer lok syringe. Qty 60 tips
Catalog Number
LLTIPS
Brand Name
Luer Loc Tips
Version/Model Number
LLTIPS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 22, 2016
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KXR
Product Code Name
Applicator, Resin
Public Device Record Key
8b78def0-91af-4d03-8d25-091cf6b8db62
Public Version Date
August 21, 2019
Public Version Number
6
DI Record Publish Date
August 04, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 73 |
2 | A medical device with a moderate to high risk that requires special controls. | 279 |