Dornier Thulio Performance Fiber K2016369

GUDID 10816959021884

INNOVAQUARTZ LLC

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 10816959021884
• NIH Device Record Key: 565dec70-2f2c-4322-ae6e-cabb07a1b649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dornier Thulio Performance Fiber
• Version Model Number: 200um Reusable Fiber
• Catalog Number: K2016369
• Company DUNS: 079295103
• Company Name: INNOVAQUARTZ 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: false
• 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: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com
• Phone: 844-776-3539
• Email: info@proflexfibers.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816959021887 [Primary]
GS1	10816959021884 [Package]; Contains: 00816959021887; Package: Carton [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180140

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

[10816959021884]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-02
• Device Publish Date: 2025-04-24

On-Brand Devices [Dornier Thulio Performance Fiber]

• 10816959021884: 200um Reusable Fiber
• 10816959021877: 200um Single-Use Fiber