ELEVATE™ ENT Instrumentation Set - 11 321016

GUDID 00852306007296

ELEVATE™ ENT Instrumentation Set of 11 Elevate ENT Handpieces and 1 tray

OMNIGUIDE, INC.

Urogenital surgical laser system beam guide, reusable

• Primary Device ID: 00852306007296
• NIH Device Record Key: cde83a02-a0e4-462a-959c-2387cbcb849a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELEVATE™ ENT Instrumentation Set - 11
• Version Model Number: 321016
• Catalog Number: 321016
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852306007296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081939

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00852306007296]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

Devices Manufactured by OMNIGUIDE, INC.

• 00894338002672 - BeamPath NEURO-L Fiber: 2021-04-07 Laser Fiber
• 00894338002818 - BeamPath ROBOTIC fiber: 2021-04-07 Laser Fiber
• 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
• 00852306007708 - TRIO Handpiece: 2019-06-14 The OmniGuide TRIO multi-functional handpiece combines three fundamental surgical functions into one lightweight and compact han
• 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