Duns Number:016069284
Device Description: MediCore's LiteTouch Luer Lock Hypodermic Syringe w/Needle
Catalog Number
-
Brand Name
LiteTouch
Version/Model Number
716LW
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)
Yes
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
def74ae3-76ca-4aca-9537-cd4761771aba
Public Version Date
October 23, 2019
Public Version Number
9
DI Record Publish Date
September 22, 2016
Package DI Number
10732671171624
Quantity per Package
100
Contains DI Package
00732671071620
Package Discontinue Date
-
Package Status
-
Package Type
Chipboard Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |