Duns Number:047047543
Device Description: SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG
Catalog Number
324910
Brand Name
BD Ultra-Fine Insulin Syringes, 3/10mL x 6MM Half-Unit Scale
Version/Model Number
324910
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
80f12d88-a9cc-4d01-bc39-4409cdd2bd70
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 23, 2018
Package DI Number
50382903249102
Quantity per Package
5
Contains DI Package
00382903249107
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 |