Duns Number:080061451
Device Description: Insulin Pen Needle Sterile Single Use Pen Needle 31G 0.25x 6m. Fits most Insulin Pens 100p Insulin Pen Needle Sterile Single Use Pen Needle 31G 0.25x 6m. Fits most Insulin Pens 100pcs per 1 Box
Catalog Number
-
Brand Name
HEPRO.US - Needle Pen Tip 1 Box 100pcs
Version/Model Number
BX - Insulin Pen Needles
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
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
8111babc-6178-4d50-8815-ec1f77d106b2
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
June 21, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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. | 20 |