Duns Number:069590113
Device Description: Used to inject insulin into the body. In addition, the device is designed to aid in the pr Used to inject insulin into the body. In addition, the device is designed to aid in the prevention of needle stick injuries.
Catalog Number
-
Brand Name
SOL-CARE™ Insulin Safety Syringe with Fixed Needle
Version/Model Number
100002IM
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
MEG
Product Code Name
SYRINGE, ANTISTICK
Public Device Record Key
595f17b2-c7b5-47ff-9032-e7214a1478f6
Public Version Date
February 18, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
20818392014802
Quantity per Package
10
Contains DI Package
10818392014805
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 161 |