InnoVoyce Laser Fiber I0128-ASY-300063-400

GUDID 00860011812166

InnoVoyce Laser Fiber .400 1 Pack RFID

Innovoyce LLC

General/multiple surgical laser system beam guide, single-use

• Primary Device ID: 00860011812166
• NIH Device Record Key: 2b5ffb94-e84c-46a8-85c7-a600e758ceff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InnoVoyce Laser Fiber
• Version Model Number: B
• Catalog Number: I0128-ASY-300063-400
• Company DUNS: 118104468
• Company Name: Innovoyce LLC
• 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: true
• Lot Batch: false
• Serial Number: true
• 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: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com
• Phone: +1 617 865 9401
• Email: info@InnoVoyce.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011812135 [Primary]
GS1	00860011812166 [Package]; Contains: 00860011812135; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220793

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2024-08-05
• Device Publish Date: 2024-07-26

On-Brand Devices [InnoVoyce Laser Fiber]

• 00860004755975: InnoVoyce Laser Fiber .600 1 Pack
• 00860004755968: InnoVoyce Laser Fiber .400 1 Pack
• 00860004755951: InnoVoyce Laser Fiber .300 1 Pack
• 00860011812173: InnoVoyce Laser Fiber .600 1 Pack RFID
• 00860011812166: InnoVoyce Laser Fiber .400 1 Pack RFID
• 00860011812159: InnoVoyce Laser Fiber .300 1 Pack RFID