Duns Number:988402590
Device Description: PEN NDL 32G 4MM PRO 100 BOX 1200 US
Catalog Number
320550
Brand Name
BD Nano 2nd Gen Pen Needle
Version/Model Number
320550
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
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
d6332ec2-d371-4ecc-a16a-75e4f00a4443
Public Version Date
May 16, 2019
Public Version Number
1
DI Record Publish Date
May 08, 2019
Package DI Number
50382903205504
Quantity per Package
12
Contains DI Package
00382903205509
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 |