Assure® ID DUO PRO Safety Pen Needles 31gx5mm 100's

GUDID 10015482277533

Assure ID DUO PRO Safety Pen Needles are disposable, sterile needles intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal 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 ID10015482277533
NIH Device Record Keye33c1e21-f767-4e0a-8a77-2d48743342f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAssure® ID DUO PRO Safety Pen Needles 31gx5mm 100's
Version Model Number277531
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
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx
Phone1(800)818-8877
Emailxxx@xxx.xxx

Device Dimensions

Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100015482277536 [Primary]
GS110015482277533 [Package]
Contains: 00015482277536
Package: Carton [12 Units]
In Commercial Distribution
GS150015482277531 [Unit of Use]

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 Date2021-10-11
Device Publish Date2021-10-01