Duns Number:428067896
Device Description: PEN NEEDLE 31GX5/16" 0,25X8mm
Catalog Number
00022990000070
Brand Name
PIC INSUPEN
Version/Model Number
00022990000070
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"
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
d8c73692-c83e-49c3-a7fd-2e190f8ac186
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 05, 2016
Package DI Number
50815832020066
Quantity per Package
12
Contains DI Package
00815832020061
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
12 units master box