Duns Number:422528088
Device Description: droplet insulin syringe with fixed needle is a sterile single use syringe for the injectio droplet insulin syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
Catalog Number
6025
Brand Name
droplet insulin syringe
Version/Model Number
0.3ml, 31G x 8mm
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
1e1f5a28-ad2a-45b6-85e7-7ca63bfbd73b
Public Version Date
July 15, 2019
Public Version Number
1
DI Record Publish Date
July 07, 2019
Package DI Number
25907996097139
Quantity per Package
5
Contains DI Package
05907996097050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |