MegaBeam® Fiber Optic Delivery System with Additio AP-400-15

GUDID 04049089300607

Ceram Optec SIA

General/multiple surgical laser system beam guide, single-use, sterile

• Primary Device ID: 04049089300607
• NIH Device Record Key: c579c45a-8d0d-4b22-b7d0-7c7dc1f42a27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MegaBeam® Fiber Optic Delivery System with Additio
• Version Model Number: MegaBeam® Single Use Handpiece 400um, 15 deg, noID
• Catalog Number: AP-400-15
• 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: 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	04049089100603 [Primary]
GS1	04049089200600 [Package]; Contains: 04049089100603; Package: Box [1 Units]; In Commercial Distribution
GS1	04049089300607 [Package]; Contains: 04049089200600; Package: Box [5 Units]; In Commercial Distribution

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: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2017-03-07

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

• 04049089300614: MegaBeam® Single Use Handpiece 400um, 30 deg, noID
• 04049089300607: MegaBeam® Single Use Handpiece 400um, 15 deg, noID
• 04049089300591: MegaBeam® Single Use Handpiece 400um, 0 deg, noID
• 04049089300584: MegaBeam® Single Use Bare Fiber 600um, Ball Tip, I
• 04049089300577: MegaBeam® Single Use Bare Fiber 600um, Flat Tip Ma
• 04049089300560: MegaBeam® Single Use Bare Fiber 1000um, Flat Tip M
• 04049089300553: MegaBeam® Single Use Bare Fiber 365um, Flat Tip BT
• 04049089300546: MegaBeam® Single Use Bare Fiber 365um, Flat Tip DO
• 04049089300539: MegaBeam® Single Use Bare Fiber 230um, Flat Tip, I
• 04049089300522: MegaBeam® Single Use Bare Fiber 600um, Flat Tip, I
• 04049089300515: MegaBeam® Single Use Bare Fiber 1000um, Flat Tip,
• 04049089300508: MegaBeam® Single Use Bare Fiber 400um, Flat Tip, I
• 04049089300492: MegaBeam® Single Use Bare Fiber 600um, Flat Tip FT
• 04049089300485: MegaBeam® Single Use Bare Fiber 1000um, Flat Tip F
• 04049089300478: MegaBeam® Single Use Bare Fiber 600um, Flat Tip PF