Duns Number:016069284
Device Description: Insulin Pen Needle 32ga X 4.0mm
Catalog Number
931
Brand Name
PIP
Version/Model Number
931
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 30, 2025
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)
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
81633570-79cd-4950-8197-5eb7b54a1225
Public Version Date
January 07, 2020
Public Version Number
1
DI Record Publish Date
December 30, 2019
Package DI Number
30732671309311
Quantity per Package
4
Contains DI Package
20732671209317
Package Discontinue Date
December 30, 2025
Package Status
In Commercial Distribution
Package Type
Corrugate Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |