Duns Number:716217877
Device Description: TSK STERiJECT Premium Disposable Hypodermic Needle
Catalog Number
-
Brand Name
STERiJECT TM
Version/Model Number
HPC-30013E
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K970370,K970370,K970370,K970370
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
8655796b-5577-4be7-ab23-4eb68ef332e7
Public Version Date
December 15, 2020
Public Version Number
2
DI Record Publish Date
November 20, 2020
Package DI Number
14571225317608
Quantity per Package
2
Contains DI Package
04571225317601
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |