Duns Number:069590113
Device Description: Intended for medical purposes for the manual aspiration of insulin (U-100 Insulin Only), a Intended for medical purposes for the manual aspiration of insulin (U-100 Insulin Only), and for the injection of insulin into parts of the body below the surface skin.
Catalog Number
-
Brand Name
SOL-M™ U-100 Insulin Syringe with Fixed Needle
Version/Model Number
1612512
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
6e5f4132-c595-4d93-b56e-878b9c2b85ae
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
Package DI Number
20818392015816
Quantity per Package
8
Contains DI Package
10818392015819
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 |