Duns Number:317326411
Device Description: HSW HENKE-JECT® 27G 1 1/2 - 0,40 x 40 MM
Catalog Number
8300022136
Brand Name
HSW HENKE-JECT®
Version/Model Number
8300022136
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
465d88de-a6ed-465f-b57a-024b6385f84f
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
March 26, 2019
Package DI Number
04035873061045
Quantity per Package
40
Contains DI Package
04035873061038
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 |