Duns Number:689512763
Device Description: US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection nee US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major brands of injection pens. This needle is a device for subcutaneous injection of medicines used for pen type of insulin syringe as subcutaneous injectables.
Catalog Number
-
Brand Name
US DIAGNOSTICS Pen Needles, 31G x 8MM, 50ea
Version/Model Number
100100
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160575,K160575,K160575,K160575
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
b6b9a277-7b49-4c6d-b932-72b8180b84d6
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 24, 2018
Package DI Number
20857513006388
Quantity per Package
5
Contains DI Package
10857513006381
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Box