Duns Number:180572216
Device Description: EXEL 2-3CC Amber Syringe Only Luer Lock W/Tip Cap Single Unit
Catalog Number
26209
Brand Name
EXEL 2-3CC Amber Syringe
Version/Model Number
26209
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
f58c90da-2709-406e-aea8-6e0bfa38b4da
Public Version Date
February 04, 2019
Public Version Number
1
DI Record Publish Date
January 02, 2019
Package DI Number
10020221262091
Quantity per Package
100
Contains DI Package
00020221262094
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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 82 |