Ultra-Care Pen Needles 31G 1/4" 100 Ct

GUDID 00372217006015

Insulin Pen Needle

ARISE MEDICAL LLC

Autoinjector needle

• Primary Device ID: 00372217006015
• NIH Device Record Key: 3cba238e-00a8-40fe-9d48-3c857ed29b78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra-Care Pen Needles 31G 1/4" 100 Ct
• Version Model Number: 240393
• Company DUNS: 081149273
• Company Name: ARISE MEDICAL LLC
• Device Count: 100
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372217006015 [Primary]
GS1	00372217006268 [Package]; Package: Case [12 Units]; In Commercial Distribution
GS1	00372217006510 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133059

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-20
• Device Publish Date: 2018-11-29

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