Elevate™ ENT Elite Fiber 322001

GUDID 00894338002825

Laser Fiber

OMNIGUIDE, INC.

Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 00894338002825
• NIH Device Record Key: 369879b6-7adc-4c7c-be92-61b99d1e3593
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elevate™ ENT Elite Fiber
• Version Model Number: 322001
• Catalog Number: 322001
• Company DUNS: 030124221
• Company Name: OMNIGUIDE, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894338002825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070157

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-07
• Device Publish Date: 2016-09-22

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• 00894338002825 - Elevate™ ENT Elite Fiber: 2021-04-07 Laser Fiber
• 00894338002849 - Omniguide Select Fiber: 2021-04-07 Laser Fiber
• 00894338002856 - Velocity™ High Performance Fiber: 2021-04-07 Laser Fiber
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• 00852306007715 - Beacon Advanced Energy CO2 Laser System: 2019-06-06 A 30 watt Beacon Advanced Energy CO2 Laser System for Surgical use with ability to use line of sight laser energy or fiber suppl
• 10894338002693 - Gas Filter Unit: 2018-07-06 Gas Filter Unit, Box of 10