Duns Number:422528088
Device Description: Sterile single use Micron, droplet® pen needles, intended to be used with a pen injector d Sterile single use Micron, droplet® pen needles, intended to be used with a pen injector device for the subcutaneous injection of drugs.
Catalog Number
7921
Brand Name
Micron, droplet, pen needles
Version/Model Number
34G x 3.5 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)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
0af284c6-2979-4d49-8468-c893161fcc8d
Public Version Date
December 07, 2020
Public Version Number
2
DI Record Publish Date
October 30, 2020
Package DI Number
15907996098849
Quantity per Package
40
Contains DI Package
05907996098842
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |