Duns Number:988402590
Device Description: PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY
Catalog Number
320883
Brand Name
BD Nano Ultra-Fine Pen Needles, 32G x 4MM Mail Order
Version/Model Number
320883
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
K131358,K131358,K131358
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
7175999b-ad75-4077-951b-4c8a121af9c0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 03, 2016
Package DI Number
50382903208833
Quantity per Package
12
Contains DI Package
00382903208838
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. | 9 |