Duns Number:069590113
Device Description: SOL-M 0.5ml Insulin Syringe (PE Bag) 28G x 1/2”
Catalog Number
-
Brand Name
SOL-M Insulin Syringe
Version/Model Number
1652812B
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
8c304f6b-8817-4cf2-87f4-5cd715e89cc5
Public Version Date
July 11, 2019
Public Version Number
1
DI Record Publish Date
July 03, 2019
Package DI Number
20818392019821
Quantity per Package
10
Contains DI Package
10818392019824
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 |