Duns Number:006922009
Device Description: Publix 5mm x 31 gauge pen needle 100ct
Catalog Number
-
Brand Name
Publix
Version/Model Number
967468
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)
-
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
cd16dfc7-b014-454d-b41c-cc18d2b83987
Public Version Date
May 31, 2021
Public Version Number
1
DI Record Publish Date
May 21, 2021
Package DI Number
30041415093783
Quantity per Package
12
Contains DI Package
20041415093786
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
casse
| 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 |