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 insulin.
Catalog Number
7915
Brand Name
MICRON, droplet pen needle
Version/Model Number
34G x 3.5mm
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
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
470e447d-a644-48fe-a58d-9ecd0215a12e
Public Version Date
February 03, 2020
Public Version Number
1
DI Record Publish Date
January 24, 2020
Package DI Number
15907996096166
Quantity per Package
40
Contains DI Package
05907996096169
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 |