Duns Number:532670536
Device Description: A female luer connector equipped with a chip having 3 microneedles; each microneedle is 0. A female luer connector equipped with a chip having 3 microneedles; each microneedle is 0.6 mm (600 micron) in length (height).This device can be mounted on any standard syringe (luer slip or luer lock connection)
Catalog Number
-
Brand Name
MicronJet 600
Version/Model Number
AS4018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092746,K092746
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
11be6d5c-d3a8-4da1-9977-8f9c6d56449b
Public Version Date
October 23, 2019
Public Version Number
6
DI Record Publish Date
August 01, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-