Duns Number:047047543
Device Description: SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
Catalog Number
328418
Brand Name
BD Ultra-Fine 2 Insulin Syringes, 1mL x 8MM
Version/Model Number
328418
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
87df8fe0-6020-4a64-8500-3777241959a8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 03, 2016
Package DI Number
50382903284189
Quantity per Package
5
Contains DI Package
00382908418034
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 |