Duns Number:422528088
Device Description: 4 pcs sterile, single use droplet® pen needles per bag, intended to be used with a pen inj 4 pcs sterile, single use droplet® pen needles per bag, intended to be used with a pen injector device for the subcutaneous injection of insulin and drugs.
Catalog Number
8120
Brand Name
droplet® pen needles
Version/Model Number
32G x 5 mm
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
d8437063-4ea0-4c72-906d-2a3b931155f5
Public Version Date
December 08, 2020
Public Version Number
5
DI Record Publish Date
January 15, 2019
Package DI Number
15907996095404
Quantity per Package
260
Contains DI Package
05907996095407
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |