Duns Number:043081723
Device Description: Advocate Pen Needle 31G 5MM 3/16 " 100 Count, thin sharp extra lubricated tri-bevel steril Advocate Pen Needle 31G 5MM 3/16 " 100 Count, thin sharp extra lubricated tri-bevel sterile tip, mini & short single use needles
Catalog Number
616
Brand Name
Advocate Pen Needle 31G 5MM 100 Count
Version/Model Number
616
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
c2c699db-cc51-4dba-a397-eaf5a322084e
Public Version Date
July 22, 2020
Public Version Number
7
DI Record Publish Date
August 20, 2016
Package DI Number
10894046001742
Quantity per Package
12
Contains DI Package
00894046001745
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
616-C
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |