MegaBeam® Reusable Fiber Optic Delivery System 101145

GUDID 04049089300409

Ceram Optec SIA

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 04049089300409
• NIH Device Record Key: b2ab3a7d-0490-4851-83d8-06695468a7c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MegaBeam® Reusable Fiber Optic Delivery System
• Version Model Number: MegaBeam® Reusable Bare Fiber 365um, Flat Tip, noI
• Catalog Number: 101145
• Company DUNS: 506069240
• Company Name: Ceram Optec SIA
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049089100405 [Primary]
GS1	04049089200402 [Package]; Contains: 04049089100405; Package: Box [5 Units]; In Commercial Distribution
GS1	04049089300409 [Package]; Contains: 04049089200402; Package: Box [2 Units]; In Commercial Distribution

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

[04049089300409]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2017-01-31

On-Brand Devices [MegaBeam® Reusable Fiber Optic Delivery System]

• 04049089300423: MegaBeam® Reusable Bare Fiber 1000um, Flat Tip, no
• 04049089300416: MegaBeam® Reusable Bare Fiber 550um, Flat Tip, noI
• 04049089300409: MegaBeam® Reusable Bare Fiber 365um, Flat Tip, noI
• 04049089300393: MegaBeam® Reusable Bare Fiber 230um, Flat Tip, noI