EZ-Tip 7-72-4135/20

GUDID 05060170181546

Assisted Reproduction Microtools (Pipettes)

RESEARCH INSTRUMENTS LIMITED

Assisted reproduction microtool

• Primary Device ID: 05060170181546
• NIH Device Record Key: c1d5e4e1-8d05-446d-bda6-5f06eb41753a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Tip
• Version Model Number: 135 micron tip id
• Catalog Number: 7-72-4135/20
• Company DUNS: 536139413
• Company Name: RESEARCH INSTRUMENTS LIMITED
• Device Count: 20
• DM Exempt: true
• 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: false

Customer Support Contacts

• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com
• Phone: 4546790202
• Email: origio@origio.com

Device Dimensions

• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer
• Lumen/Inner Diameter: 135 Micrometer

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight (UV)

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060170181546 [Primary]
GS1	05060170185957 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161275

FDA Product Code

• MQH: MICROTOOLS, ASSISTED REPRODUCTION (PIPETTES)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-22

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