Duns Number:422528088
Device Description: Single LEADER pen needles, intended to be used with a pen injector device for the subcutan Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous injection of drugs.
Catalog Number
8470
Brand Name
LEADER, pen needles
Version/Model Number
31G 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)
-
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
5216f365-4fdd-45b6-95ab-98cfbfbf807b
Public Version Date
August 16, 2021
Public Version Number
3
DI Record Publish Date
December 19, 2019
Package DI Number
50096295138769
Quantity per Package
24
Contains DI Package
00096295138764
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 |