Duns Number:422528088
Device Description: 110 pcs sterile single use droplet® pen needles per box, intended to be used with a pen in 110 pcs sterile single use droplet® pen needles per box, intended to be used with a pen injector device for the subcutaneous injection of insulin.
Catalog Number
9083
Brand Name
droplet® pen needle
Version/Model Number
32G x 8mm
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
acb433e4-8e6d-4639-ad14-4ead168d8882
Public Version Date
December 08, 2020
Public Version Number
3
DI Record Publish Date
August 03, 2018
Package DI Number
15907996095329
Quantity per Package
10
Contains DI Package
05907996095322
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |