Duns Number:180572216
Device Description: EXEL 1CC W/ SAFETY NDL 25G X 5/8
Catalog Number
27044
Brand Name
EXEL Syringes
Version/Model Number
27044
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
K861153,K861153,K861153
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
679ab8e3-69b7-4055-baa9-de51ae28c949
Public Version Date
June 05, 2019
Public Version Number
1
DI Record Publish Date
May 28, 2019
Package DI Number
20020221270444
Quantity per Package
6
Contains DI Package
10020221270447
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |