OmniGuide® OmniFlex Instrument Set 341004

GUDID 00852306007234

OmniFlex Instrumentation Set, LapFlex (1 Piece), FlexGuide Ultra (1 Piece) and Tray

OMNIGUIDE, INC.

Urogenital surgical laser system beam guide, reusable

• Primary Device ID: 00852306007234
• NIH Device Record Key: f8ac3b29-41ae-48f7-a39d-23ccf399487a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniGuide® OmniFlex Instrument Set
• Version Model Number: 341004
• Catalog Number: 341004
• 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	00852306007234 [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

[00852306007234]

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

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