Duns Number:317326411
Device Description: HSW HENKE-JECT® 22G X 4 - 0,70 X 100 MM - RW /LB
Catalog Number
8300059226
Brand Name
HSW HENKE-JECT®
Version/Model Number
22Gx4-0,70x100
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
0fd6f8e3-64fb-412f-9bf6-f3ad965aea57
Public Version Date
August 03, 2022
Public Version Number
1
DI Record Publish Date
July 26, 2022
Package DI Number
04035873071129
Quantity per Package
3000
Contains DI Package
04035873071136
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |