Duns Number:422528088
Device Description: The Dropsafe® Safety Needle is used for general purpose injection and aspiration of fluids The Dropsafe® Safety Needle is used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
Catalog Number
6069
Brand Name
DropSafe Safety Needle LD
Version/Model Number
23G x 1"
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
K123684,K123684,K123684
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
88117cb2-aa6a-4ad6-9b58-2b0427fc783b
Public Version Date
September 14, 2021
Public Version Number
1
DI Record Publish Date
September 06, 2021
Package DI Number
15907996099969
Quantity per Package
100
Contains DI Package
05907996099962
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 |