Duns Number:543007373
Device Description: A device designed for the parenteral administration of a drug contained in a cartridge tha A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.
Catalog Number
HWIPN3104
Brand Name
INSULIN PEN NEEDLE
Version/Model Number
31G x 4MM
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
K133058,K133058,K133058
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
f3670dd4-1302-4344-b37a-19b792b9885a
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 12, 2022
Package DI Number
26958697605887
Quantity per Package
50
Contains DI Package
16958697605880
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-