Duns Number:422528088
Device Description: Single LEADER pen needles, intended to be used with a pen injector device for the subcuta Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous injection of insulin.
Catalog Number
8472
Brand Name
LEADER, pen needles
Version/Model Number
33G x 4 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
ee945f69-67d8-4c46-b9bf-3a6071bd4fd5
Public Version Date
January 21, 2020
Public Version Number
1
DI Record Publish Date
January 13, 2020
Package DI Number
50096295138783
Quantity per Package
12
Contains DI Package
00096295138788
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |