Duns Number:783518983
Device Description: 100ct box. 31G x 5mm Sterile Single use disposable pen needle for use with most insulin de 100ct box. 31G x 5mm Sterile Single use disposable pen needle for use with most insulin delivery systems. Includes 100 sterile needles individually wrapped.
Catalog Number
1638
Brand Name
True Comfort Pro Pen Needles 5MM 31G
Version/Model Number
I12015 or INSP31-5
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
1d00327d-d1cd-42f6-8154-0e5402ca518f
Public Version Date
April 01, 2021
Public Version Number
1
DI Record Publish Date
March 24, 2021
Package DI Number
10850027494071
Quantity per Package
50
Contains DI Package
00850027494074
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| 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 |