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
Catalog Number
7910
Brand Name
droplet ® pen needles
Version/Model Number
30G x 8 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)
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
62a54df7-986d-4494-996f-503c453ba92f
Public Version Date
January 20, 2020
Public Version Number
3
DI Record Publish Date
December 23, 2019
Package DI Number
15907996098139
Quantity per Package
12
Contains DI Package
05907996098132
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |