Duns Number:825097264
Device Description: 31G x 5/16" (8mm) Single use disposable pen needle for use with most insulin delivery syst 31G x 5/16" (8mm) Single use disposable pen needle for use with most insulin delivery systems (Insulin Pen). Includes 50 sterile needles individually wrapped.
Catalog Number
24-1217
Brand Name
Sure Comfort
Version/Model Number
24-1217
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"
-
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
K152877,K152877,K152877
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
3e7917e0-50cd-4320-955c-ab003931dd7b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 03, 2016
Package DI Number
00786227121796
Quantity per Package
6
Contains DI Package
00786227121772
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |