ASSURE® ID Insulin 0.5cc Safety Syringe

GUDID 10015482102958

Sterile Safety Syringe

ARKRAY USA, INC.

Metered-delivery hypodermic syringe/needle
Primary Device ID10015482102958
NIH Device Record Key4f76b69e-ea05-4b14-8069-3e8ef5c427de
Commercial Distribution Discontinuation2025-03-18
Commercial Distribution StatusNot in Commercial Distribution
Brand NameASSURE® ID Insulin 0.5cc Safety Syringe
Version Model Number210295
Company DUNS008171162
Company NameARKRAY USA, INC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx
Phone+1(800)566-8558
Emailxxx@xxx.xxx

Device Dimensions

Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch
Needle Gauge29 Gauge
Total Volume0.5 Milliliter
Length0.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100015482102951 [Primary]
GS110015482102958 [Package]
Contains: 00015482102951
Package: Carton [100 Units]
Discontinued: 2025-03-18
Not in Commercial Distribution
GS120015482102955 [Package]
Package: Master Shipper [5 Units]
Discontinued: 2025-03-18
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMINeedle, hypodermic, single lumen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-03-19
Device Publish Date2016-09-23

Devices Manufactured by ARKRAY USA, INC.

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10015482102958 - ASSURE® ID Insulin 0.5cc Safety Syringe2025-03-19Sterile Safety Syringe
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00015482188627 - AUTION EYE™ AI-4510 Analyzer2024-12-10 The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use.

Trademark Results [ASSURE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASSURE
ASSURE
98452802 not registered Live/Pending
Aqua Horizon LLC
2024-03-16
ASSURE
ASSURE
98235302 not registered Live/Pending
Caris MPI, Inc.
2023-10-23
ASSURE
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98144267 not registered Live/Pending
Superior Plastics Extrusion Co Inc
2023-08-22
ASSURE
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97901492 not registered Live/Pending
Resilient Floor Covering Institute, Inc.
2023-04-21
ASSURE
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97614385 not registered Live/Pending
PerkinElmer Health Sciences, Inc.
2022-09-30
ASSURE
ASSURE
97526467 not registered Live/Pending
Qualia Labs, Inc.
2022-07-29
ASSURE
ASSURE
97448887 not registered Live/Pending
PRESTIGE MARKETING, LTD.
2022-06-08
ASSURE
ASSURE
90315893 not registered Live/Pending
LSI Wallcovering, Inc.
2020-11-12
ASSURE
ASSURE
90238064 not registered Live/Pending
Azure Biotech, Inc.
2020-10-06
ASSURE
ASSURE
90030227 not registered Live/Pending
Zep IP Holding LLC
2020-07-01
ASSURE
ASSURE
88908804 not registered Live/Pending
Syed Doha, Inc.
2020-05-10
ASSURE
ASSURE
88837750 not registered Live/Pending
West Affum Holdings Corp.
2020-03-17

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