Duns Number:180572216
Device Description: Syringe, 5CC, Luer Lock, 21G x 1 1/2
Catalog Number
26213
Brand Name
EXEL Syringes
Version/Model Number
26213
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
87c3fe23-3355-4e9a-9770-c783855ffdbc
Public Version Date
September 12, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
20020221262135
Quantity per Package
8
Contains DI Package
10020221262138
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |