Duns Number:532670536
Device Description: a female luer connector equipped with a chip having three microneedles; each microneedle i a female luer connector equipped with a chip having three 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
AS4008
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 14, 2019
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
0e471c43-8699-4c95-8b9f-8b145ace1f1d
Public Version Date
October 23, 2019
Public Version Number
7
DI Record Publish Date
June 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-