Duns Number:004135503
Device Description: Insulin Pen Needle 1/2 inch length and 29 gauge
Catalog Number
98302-0148-08
Brand Name
Clever Choice Comfort EZ
Version/Model Number
Insulin Pen 29G 1/2"
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
c4ccde60-9385-4748-a6d5-e9ab035142b6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 12, 2016
Package DI Number
10898302148080
Quantity per Package
5
Contains DI Package
00898302148083
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 |