Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10's

GUDID 00015482273835

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 ID00015482273835
NIH Device Record Key79923bd5-5b3a-42b3-837f-736465236ac5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAssure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10's
Version Model Number273830
Company DUNS008171162
Company NameARKRAY USA, INC.
Device Count10
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
GS100015482273835 [Primary]
GS150015482273830 [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