Duns Number:422528088
Device Description: The DropSafe Syringe is intended for use in the aspiration and injection of fluids for med The DropSafe Syringe is intended for use in the aspiration and injection of fluids for medical purpose.
Catalog Number
6062
Brand Name
DropSafe Syringe
Version/Model Number
3ml
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
ddf0fda9-9fde-41d1-b242-61682cc21ecb
Public Version Date
April 28, 2021
Public Version Number
1
DI Record Publish Date
April 20, 2021
Package DI Number
05907996099344
Quantity per Package
100
Contains DI Package
85907996099340
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 |