NeuroBlate Optic SideFire® Laser Probe NBP-000-01

GUDID 00816589020885

3.3mm Directional Laser Probe

MONTERIS MEDICAL INC

MRI-guided laser interstitial thermal therapy system beam guide

• Primary Device ID: 00816589020885
• NIH Device Record Key: 535adc58-987c-4c05-9896-22533647491a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroBlate Optic SideFire® Laser Probe
• Version Model Number: 20891-000
• Catalog Number: NBP-000-01
• Company DUNS: 021415875
• Company Name: MONTERIS MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(866)799-7655
• Email: gglaser@monteris.com
• Phone: +1(866)799-7655
• Email: gglaser@monteris.com
• Phone: +1(866)799-7655
• Email: gglaser@monteris.com

Device Dimensions

• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589020885 [Primary]

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-19
• Device Publish Date: 2018-10-17

On-Brand Devices [NeuroBlate Optic SideFire® Laser Probe]

• 00816589020939: 3.3mm Directional Laser Probe
• 00816589020922: 3.3mm Directional Laser Probe
• 00816589020915: 3.3mm Directional Laser Probe
• 00816589020908: 3.3mm Directional Laser Probe
• 00816589020892: 3.3mm Directional Laser Probe
• 00816589020885: 3.3mm Directional Laser Probe
• 00816589020878: 3.3mm Directional Laser Probe