Duns Number:047047543
Device Description: SYRINGE 0.5ML 31GA 6MM U500 10BAG 500CS
Catalog Number
326730
Brand Name
BD Ultra-Fine Insulin Syringes, 1/2mL x 8MM
Version/Model Number
326730
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
-
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
f3b8d0aa-9bae-4b57-8aae-a5bf478f9cc2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 17, 2016
Package DI Number
50382903267304
Quantity per Package
5
Contains DI Package
00382903267309
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 |