Duns Number:047047543
Device Description: PEN NEEDLE SAFETY DUO 30G X 8MM
Catalog Number
329515
Brand Name
BD Autoshield Duo Safety Pen Needle, 8MM
Version/Model Number
329515
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
K110703,K110703,K110703
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
a3ff5f01-5ec3-4f4b-a672-f0dd7566aa6f
Public Version Date
November 02, 2020
Public Version Number
3
DI Record Publish Date
August 09, 2016
Package DI Number
50382903295154
Quantity per Package
8
Contains DI Package
00382903295159
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 |