Duns Number:043537671
Device Description: Pen Needle Kit
Catalog Number
-
Brand Name
Stradis Medical, LLC.
Version/Model Number
511389
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PQD
Product Code Name
Blood Specimen Collection Convenience Kit (Excludes Hiv)
Public Device Record Key
fc153bc1-e336-4df2-8dba-7ce9956dcbac
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
March 25, 2020
Package DI Number
M7525113895
Quantity per Package
100
Contains DI Package
M7525113890
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |