ASSURE® ID Insulin 1cc Safety Syringe

GUDID 10015482102910

Sterile Safety Syringe

ARKRAY USA, INC.

Metered-delivery hypodermic syringe/needle

• Primary Device ID: 10015482102910
• NIH Device Record Key: 6e14eff8-fc0e-41a3-9e43-cc55594f2a38
• Commercial Distribution Discontinuation: 2025-03-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ASSURE® ID Insulin 1cc Safety Syringe
• Version Model Number: 210291
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx
• Phone: +1(800)566-8558
• Email: xxx@xxx.xxx

Device Dimensions

• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter
• Needle Gauge: 29 Gauge
• Length: 0.5 Inch
• Total Volume: 1 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482102913 [Primary]
GS1	10015482102910 [Package]; Contains: 00015482102913; Package: Carton [100 Units]; Discontinued: 2025-03-18; Not in Commercial Distribution
GS1	20015482102917 [Package]; Package: Master Shipper [5 Units]; Discontinued: 2025-03-18; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103011

FDA Product Code

• FMI: Needle, hypodermic, single lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-03-19
• Device Publish Date: 2016-09-23

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• 10015482102958 - ASSURE® ID Insulin 0.5cc Safety Syringe: 2025-03-19 Sterile Safety Syringe
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