INTEGRA 3 6-54-100-05

GUDID 05060488041792

Assisted Reproduction Micromanipulator and Microinjector

RESEARCH INSTRUMENTS LIMITED

Assisted-reproduction micromanipulator, electric Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator Assisted reproduction electromechanical micromanipulator

• Primary Device ID: 05060488041792
• NIH Device Record Key: e21acc39-08ae-4b27-a2ce-64cf046c18a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRA 3
• Version Model Number: Integra 3 Thermosafe Olympus No Syringes
• Catalog Number: 6-54-100-05
• Company DUNS: 536139413
• Company Name: RESEARCH INSTRUMENTS LIMITED
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05060488041792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003142

FDA Product Code

• MQJ: MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION

Sterilization

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

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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