Unistik Pro

GUDID 00384701644030

Unistik Pro Safety Lancet - 28G x 1.2mm

OWEN MUMFORD LIMITED

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• Primary Device ID: 00384701644030
• NIH Device Record Key: a4804809-b4cf-4302-8480-5d1e610209e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unistik Pro
• Version Model Number: AT 1644
• Company DUNS: 217266915
• Company Name: OWEN MUMFORD LIMITED
• Device Count: 200
• 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: true
• OTC Over-The-Counter: true

Device Dimensions

• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter
• Needle Gauge: 28 Gauge
• Depth: 1.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384701644009 [Unit of Use]
GS1	00384701644016 [Primary]
GS1	00384701644030 [Package]; Contains: 00384701644016; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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: 2023-02-15
• Device Publish Date: 2023-02-07

On-Brand Devices [Unistik Pro]

• 00384701644030: Unistik Pro Safety Lancet - 28G x 1.2mm
• 00384701634031: Unistik Pro Safety Lancet - 25G x 1.6mm
• 00384701614033: Unistik Pro Safety Lancet - 21G x 2.0mm