Duns Number:069590113
Device Description: The SOL-GUARD™ Safety Syringe is intended for the delivery of U-100 insulin. The SOL-GUARD The SOL-GUARD™ Safety Syringe is intended for the delivery of U-100 insulin. The SOL-GUARD™ Safety Sleeve covers the needle when activated. In the activated position, the Safety Shield guards against accidental needle stick.
Catalog Number
-
Brand Name
SOL-GUARD™ Insulin Safety Syringe with Fixed Needle
Version/Model Number
2531516SG
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
MEG
Product Code Name
SYRINGE, ANTISTICK
Public Device Record Key
31d57b80-e663-4913-8db1-e925a947276d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
Package DI Number
20818392013652
Quantity per Package
8
Contains DI Package
10818392013655
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 |