Duns Number:788472314
Device Description: 10cc (Light Green)
Catalog Number
LLS-10-LG
Brand Name
Luer Loc Standard Syringe
Version/Model Number
LLS-10-LG
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
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
FMF
Product Code Name
Syringe, piston
Public Device Record Key
1d80aa59-8d53-4396-9558-c5911472cd5c
Public Version Date
September 12, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
20813079020114
Quantity per Package
10
Contains DI Package
10813079020117
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 32 |