Unistik

GUDID 00384701015038

Unistik Safety Lancet Economy - 21G

OWEN MUMFORD LIMITED

Manual blood lancing device, single-use

• Primary Device ID: 00384701015038
• NIH Device Record Key: f8d2edec-e5e3-4a04-b012-eb265e7f743c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unistik
• Version Model Number: AT 1015
• 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: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge
• Needle Gauge: 21 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384701015007 [Unit of Use]
GS1	00384701015014 [Primary]
GS1	00384701015038 [Package]; Contains: 00384701015014; 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

Devices Manufactured by OWEN MUMFORD LIMITED

• 00384701402036 - Unistik Touch: 2023-04-07 Unistik Touch contact activated safety lancets - 23G x 2.0mm - medium flow
• 00384701015038 - Unistik: 2023-02-15Unistik Safety Lancet Economy - 21G
• 00384701015038 - Unistik: 2023-02-15 Unistik Safety Lancet Economy - 21G
• 00384701027024 - Unistik 3: 2023-02-15 Unistik 3 Safety Lancet Gentle - 30G
• 00384701614033 - Unistik Pro: 2023-02-15 Unistik Pro Safety Lancet - 21G x 2.0mm
• 00384701634031 - Unistik Pro: 2023-02-15 Unistik Pro Safety Lancet - 25G x 1.6mm
• 00384701644030 - Unistik Pro: 2023-02-15 Unistik Pro Safety Lancet - 28G x 1.2mm
• 00384701404030 - Unistik Touch - Contact Activated Safety Lancet - 23G x 2.0mm: 2021-04-12 Sterile, single use safety lancet
• 00384701412035 - Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm: 2021-04-12 Sterile, single use safety lancet