NeuroBlate Optic FullFire® Laser Probe DTP-000-01

GUDID 00816589020953

3.3mm Diffusing Tip Laser Probe

MONTERIS MEDICAL INC

MRI-guided laser interstitial thermal therapy system beam guide

• Primary Device ID: 00816589020953
• NIH Device Record Key: 52217841-80ee-4c03-b750-580965772ab5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroBlate Optic FullFire® Laser Probe
• Version Model Number: 20893-000
• Catalog Number: DTP-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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589020953 [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

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• 00816589020977: 3.3mm Diffusing Tip Laser Probe
• 00816589020960: 3.3mm Diffusing Tip Laser Probe
• 00816589020953: 3.3mm Diffusing Tip Laser Probe
• 00816589020946: 3.3mm Diffusing Tip Laser Probe