Duns Number:783518983
Device Description: 100ct box. 31G x 5/16 (8mm) Single use disposable pen needle for use with most insulin del 100ct box. 31G x 5/16 (8mm) Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.
Catalog Number
7119
Brand Name
Pro Comfort Pen Needles 8mm
Version/Model Number
I23108 or INSP31-8
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
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
3361178e-bf80-4647-82e5-f348ca854535
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
July 15, 2016
Package DI Number
10850632007116
Quantity per Package
50
Contains DI Package
00850632007119
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |