Duns Number:047047543
Device Description: SYRINGE 0.5ML 31GA 8MM 10 BAG 500
Catalog Number
328509
Brand Name
Insulin Syringes, 1/2mL 31G x 8MM
Version/Model Number
328509
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
K024112,K024112,K024112
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
8a08cf3a-df76-412f-b139-81ffe26e1ef0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 10, 2016
Package DI Number
50382903285094
Quantity per Package
5
Contains DI Package
00681131311762
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |