Duns Number:422528088
Device Description: 100 pcs sterile, single use droplet® pen needles per box, intended to be used with a pen i 100 pcs sterile, single use droplet® pen needles per box, intended to be used with a pen injector device for the subcutaneous injection of insulin or drugs.
Catalog Number
8313
Brand Name
droplet® pen needles
Version/Model Number
32G x 6mm
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)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
c2237d5c-2d26-4942-8a1b-4eb53eede4ed
Public Version Date
December 08, 2020
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
15907996093097
Quantity per Package
30
Contains DI Package
05907996093090
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 |