Duns Number:006922009
Device Description: Publix 3/10cc, 1/2 inch x 30 gauge insulin syringe, 100ct
Catalog Number
-
Brand Name
Publix Regular Needle Insulin Syringe
Version/Model Number
901899
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
K062702,K062702,K062702,K062702
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
96cacaad-5ce3-4544-bfbd-a3e03719a34a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
30041415015785
Quantity per Package
5
Contains DI Package
20041415015788
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |