Duns Number:422528088
Device Description: DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached DropSafe® Insulin Safety Syringe with Fixed Needle is hypodermic syringe with an attached safety shield to cover the needle. This device is intended for the delivery of U-100 insulin.
Catalog Number
6080
Brand Name
DropSafe® Insulin Safety Syringe with Fixed Needle
Version/Model Number
1ml 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"
-
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
K132681,K132681,K132681
Product Code
MEG
Product Code Name
Syringe, Antistick
Public Device Record Key
ab2c307f-b644-434a-97bd-6aa3377ce25f
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 10, 2021
Package DI Number
05903999600730
Quantity per Package
100
Contains DI Package
85903999600736
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shelf box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |