Duns Number:688432407
Catalog Number
-
Brand Name
JBP Nanoneedle
Version/Model Number
JBP Nanoneedle 23Gx13mm
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
K092831,K092831,K092831,K092831
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
faab3f15-d6f9-4c45-8b3e-843d43ebd320
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
October 23, 2017
Package DI Number
38809407781665
Quantity per Package
4000
Contains DI Package
28809407781668
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |