Unistik 3

GUDID 00384701028038

Unistik 3 Safety Lancets- Gentle 30G

OWEN MUMFORD USA INCORPORATED

Manual blood lancing device, single-use

• Primary Device ID: 00384701028038
• NIH Device Record Key: 547b27da-a85b-48bc-9348-ea64cfb878e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unistik 3
• Version Model Number: AT 1028
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• Device Count: 25
• 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: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384701028007 [Unit of Use]
GS1	00384701028014 [Primary]
GS1	00384701028038 [Package]; Contains: 00384701028014; Package: Case [100 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: 2022-10-26
• Device Publish Date: 2022-10-18

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