Duns Number:069590113
Device Description: Used to inject medicines and vaccines into, or withdraw fluids from the body. In addition, Used to inject medicines and vaccines into, or withdraw fluids from the body. In addition, the SOL-CARE™ Safety Needle is designed to aid in the prevention of needle stick injuries.
Catalog Number
-
Brand Name
SOL-CARE™ Luer Lock Syringe with Safety Needle
Version/Model Number
12338SN
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
FMF
Product Code Name
Syringe, piston
Public Device Record Key
399f1e05-943c-4baa-9a78-3fca61b746c1
Public Version Date
September 12, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
10818392014317
Quantity per Package
100
Contains DI Package
00818392014310
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 161 |