Duns Number:069590113
Device Description: The SOL-GUARD™ Safety Syringe is intended for the delivery of vaccines. The SOL-GUARD™ Saf The SOL-GUARD™ Safety Syringe is intended for the delivery of vaccines. 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™ TB Safety Syringe with Fixed Needle
Version/Model Number
200090SG
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
f1f6f68f-7a60-4404-820a-a8aeff15c575
Public Version Date
September 12, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
20818392014284
Quantity per Package
8
Contains DI Package
10818392014287
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 |