Duns Number:043081723
Device Description: Advocate Pen Needle 31G 6MM sterile 100 Count
Catalog Number
643
Brand Name
Advocate Pen Needle 31G 6MM
Version/Model Number
643
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)
Yes
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
705d6bff-2807-42e6-9918-abb2cc5323e1
Public Version Date
November 01, 2022
Public Version Number
6
DI Record Publish Date
December 12, 2016
Package DI Number
15852982006134
Quantity per Package
12
Contains DI Package
00852982006132
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
643-C
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |