Duns Number:066087031
Device Description: Disposable Syringe, Luer Slip, Centrical, 20 ml, Sterile
Catalog Number
SLS20A3
Brand Name
Endure
Version/Model Number
SLS20A3-0520
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"
Yes
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
efe63ae1-26cd-4b99-b762-019ac7de15d6
Public Version Date
September 23, 2020
Public Version Number
1
DI Record Publish Date
September 15, 2020
Package DI Number
00840118604048
Quantity per Package
100
Contains DI Package
00840118604031
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |