Duns Number:006922009
Device Description: Publix 6mm x 31 gauge pen needle, 100ct
Catalog Number
-
Brand Name
Publix Extra Short Pen Needle
Version/Model Number
973168
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100812,K100812,K100812
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
7bf75e56-c9b4-4dba-b98b-6f68889e67cc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
30041415074782
Quantity per Package
24
Contains DI Package
20041415074785
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 17 |