Duns Number:317326411
Device Description: HSW HENKE-JECT® 3-TLG. 2 ML (2,5 ML) BK 20G X 1 - 0,90 X 25 MM
Catalog Number
5042I000V0
Brand Name
HSW HENKE-JECT®
Version/Model Number
5042I000V0
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
c16189cc-79da-471d-b8c3-7fe5a4f406fa
Public Version Date
April 27, 2020
Public Version Number
1
DI Record Publish Date
April 17, 2020
Package DI Number
04035873062752
Quantity per Package
25
Contains DI Package
04035873062745
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| 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. | 77 |