Duns Number:422528088
Device Description: Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device Syringe with Safety Needle is Luer Lock syringe with hinged-cap safety needle. This device is used for aspiration and administration of medication.
Catalog Number
6073
Brand Name
DropSafe Syringe with Safety Needle
Version/Model Number
1mL 25Gx1”
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
K101359,K101359,K101359
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
f7c7fc9d-f279-4c90-9c70-0a4e7f511f47
Public Version Date
September 14, 2021
Public Version Number
1
DI Record Publish Date
September 06, 2021
Package DI Number
15903999600324
Quantity per Package
50
Contains DI Package
05903999600327
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 |