Duns Number:422528088
Device Description: The Sterile Disposable Syringe with Safety Needle is intendend for use in the aspiration a The Sterile Disposable Syringe with Safety Needle is intendend for use in the aspiration and injection of fluids for medical purpouse.
Catalog Number
6054
Brand Name
DropSafe Syringe with Safety Needle
Version/Model Number
25G x 1 ml
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)
-
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
cf1f9c05-eaab-466d-a756-addd6a80e702
Public Version Date
April 21, 2021
Public Version Number
2
DI Record Publish Date
October 25, 2020
Package DI Number
25907996099201
Quantity per Package
12
Contains DI Package
05907996099207
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |