Duns Number:422528088
Device Description: The sterile Safety Needle is intended for use in the aspiration and injection of fluids fo The sterile Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose.
Catalog Number
6059
Brand Name
DropSafe Safety Needle
Version/Model Number
25G
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
6495da7b-976d-4f23-9de0-9ee53a6f361e
Public Version Date
April 28, 2021
Public Version Number
1
DI Record Publish Date
April 20, 2021
Package DI Number
05907996099313
Quantity per Package
100
Contains DI Package
85907996099319
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 |