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 ID: 00015482273835
• NIH Device Record Key: 79923bd5-5b3a-42b3-837f-736465236ac5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10's
• Version Model Number: 273830
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 10
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1(800)818-8877
• Email: xxx@xxx.xxx

Device Dimensions

• Needle Gauge: 30 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482273835 [Primary]
GS1	50015482273830 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191853

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-29
• Device Publish Date: 2020-01-21