MegaBeam® Endo-ENT Probe ENT-24-COH-S

GUDID 04049089300324

Ceram Optec SIA

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

• Primary Device ID: 04049089300324
• NIH Device Record Key: 61811165-56b0-4b28-8170-55995c999f83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MegaBeam® Endo-ENT Probe
• Version Model Number: MegaBeam® Endo-ENT Probe, 24Ga, COH-S, noID
• Catalog Number: ENT-24-COH-S
• 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	04049089100320 [Primary]
GS1	04049089200327 [Package]; Contains: 04049089100320; Package: Box [5 Units]; In Commercial Distribution
GS1	04049089300324 [Package]; Contains: 04049089200327; Package: Box [2 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® Endo-ENT Probe]

• 04049089300386: MegaBeam® Endo-ENT Probe, 24Ga, SMA-S, noID
• 04049089300379: MegaBeam® Endo-ENT Probe, 24Ga, SMA-H, noID
• 04049089300362: MegaBeam® Endo-ENT Probe, 24Ga, SMA-G, noID
• 04049089300355: MegaBeam® Endo-ENT Probe, 24Ga, HGM-S, noID
• 04049089300348: MegaBeam® Endo-ENT Probe, 24Ga, HGM-H, noID
• 04049089300331: MegaBeam® Endo-ENT Probe, 24Ga, HGM-G, noID
• 04049089300324: MegaBeam® Endo-ENT Probe, 24Ga, COH-S, noID
• 04049089300317: MegaBeam® Endo-ENT Probe, 24Ga, COH-H, noID
• 04049089300300: MegaBeam® Endo-ENT Probe, 24Ga, COH-G, noID