Assure® ID Safety Pen Needles, 30G x 8mm Sample 10's

GUDID 00015482280307

Insulin Safety Pen Needle. Intended for use with a pen injector device for the subcutaneous injection of insulin. After injection and withdrawal from the body, the safety shield automatically covers the needle to minimize the risk of accidental needle sticks.

ARKRAY USA, INC.

Autoinjector needle

• Primary Device ID: 00015482280307
• NIH Device Record Key: 3a47c013-8a9e-45cb-a356-056442e4edf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure® ID Safety Pen Needles, 30G x 8mm Sample 10's
• Version Model Number: 278030
• 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	00015482280307 [Primary]
GS1	50015482280302 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161950

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: 2020-01-22
• Device Publish Date: 2020-01-14