Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 100's

GUDID 10015482272538

Assure ID DUO-Shield Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawl from the body, the two safety shields on the patient-end and the pen connection-end automatically cover the needle and lock to minimize the risk of accidental needle sticks.

ARKRAY USA, INC.

Autoinjector needle
Primary Device ID10015482272538
NIH Device Record Key7d23e09a-281c-44ec-9e5c-c2dc8d6cb766
Commercial Distribution StatusIn Commercial Distribution
Brand NameAssure® ID DUO-Shield Safety Pen Needle 5mm x 30g 100's
Version Model Number272530
Company DUNS008171162
Company NameARKRAY USA, INC.
Device Count100
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1(800)818-8877
Emailxxx@xxx.xxx

Device Dimensions

Needle Gauge30 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100015482272531 [Primary]
GS110015482272538 [Package]
Contains: 00015482272531
Package: Case Pack [12 Units]
In Commercial Distribution
GS150015482272536 [Unit of Use]

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 Date2020-01-29
Device Publish Date2020-01-21