INSULIN PEN NEEDLE HWIPN3105

GUDID 16958697605842

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.

ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle
Primary Device ID16958697605842
NIH Device Record Key9bcc01d2-8a59-4fc8-9fc2-ae95cf28c15d
Commercial Distribution StatusIn Commercial Distribution
Brand NameINSULIN PEN NEEDLE
Version Model Number31G x 5MM
Catalog NumberHWIPN3105
Company DUNS543007373
Company NameANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106958697605845 [Primary]
GS116958697605842 [Package]
Contains: 06958697605845
Package: [100 Units]
In Commercial Distribution
GS126958697605849 [Package]
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-14
Device Publish Date2022-03-04

On-Brand Devices [INSULIN PEN NEEDLE ]

16958697605873A device designed for the parenteral administration of a drug contained in a cartridge that form
16958697605866A device designed for the parenteral administration of a drug contained in a cartridge that form
16958697605859A device designed for the parenteral administration of a drug contained in a cartridge that form
16958697605842A device designed for the parenteral administration of a drug contained in a cartridge that form
16958697605828A device designed for the parenteral administration of a drug contained in a cartridge that form
26958697605924A device designed for the parenteral administration of a drug contained in a cartridge that form
26958697605917A device designed for the parenteral administration of a drug contained in a cartridge that form
26958697605900A device designed for the parenteral administration of a drug contained in a cartridge that form
26958697605894A device designed for the parenteral administration of a drug contained in a cartridge that form
26958697605887A device designed for the parenteral administration of a drug contained in a cartridge that form

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