Duns Number:988402590
Device Description: PEN NEEDLE 32G 4MM 5B XTW 7CT CARTON
Catalog Number
320540
Brand Name
BD Nano Ultra-Fine Pen Needles, 32G x 4MM
Version/Model Number
320540
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K131358,K131358
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
200aba8c-d656-40c9-87b2-41aaeba772cb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |