Duns Number:529239746
Catalog Number
-
Brand Name
Disposable Insulin Syringe
Version/Model Number
U-100 0.5ML 29G×12mm Protective end top
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
7ce0c4cd-b263-451d-96ab-06e5a7ffad2b
Public Version Date
January 20, 2020
Public Version Number
4
DI Record Publish Date
March 31, 2017
Package DI Number
06949236201772
Quantity per Package
30
Contains DI Package
06949236200737
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 18 |