Duns Number:716217877
Device Description: TSK STERiJECT Premium Disposable Hypodermic Needle
Catalog Number
-
Brand Name
STERiJECT TM
Version/Model Number
PRE-31013
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
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
115bf589-5c68-47bb-bbe3-e974f84ada6e
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
September 17, 2016
Package DI Number
14571225315710
Quantity per Package
60
Contains DI Package
04571225315713
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |