Duns Number:004135503
Device Description: Insulin Pen Needle 1/4 inch length and 31 gauge
Catalog Number
98302-0002-00
Brand Name
Clever Choice Comfort EZ
Version/Model Number
Insulin Pen 31G 1/4" 6mm
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
23b98d28-fde2-4bd0-825a-6ea80c74176c
Public Version Date
August 30, 2019
Public Version Number
3
DI Record Publish Date
August 11, 2016
Package DI Number
10898302140008
Quantity per Package
30
Contains DI Package
00898302140001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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. | 19 |