FullFire® Select Diffusing Tip Laser Probe FFS002-01

GUDID 00816589020465

2.2mm Diffusing Tip Laser Probe

MONTERIS MEDICAL INC

MRI-guided laser interstitial thermal therapy system beam guide

• Primary Device ID: 00816589020465
• NIH Device Record Key: f651a07e-ee53-4211-8467-9d9b791cd6be
• Commercial Distribution Discontinuation: 2017-10-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FullFire® Select Diffusing Tip Laser Probe
• Version Model Number: 20624-00
• Catalog Number: FFS002-01
• 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: info@monteris.com
• Phone: +1(866)799-7655
• Email: info@monteris.com
• Phone: +1(866)799-7655
• Email: info@monteris.com

Device Dimensions

• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter
• Outer Diameter: 2.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589020465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143457

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: 2018-07-06
• Device Publish Date: 2017-03-10

On-Brand Devices [FullFire® Select Diffusing Tip Laser Probe]

• 00816589020847: 2.2mm Diffusing Tip Laser Probe
• 00816589020762: 2.2mm Diffusing Tip Laser Probe
• 00816589020755: 2.2mm Diffusing Tip Laser Probe
• 00816589020748: 2.2mm Diffusing Tip Laser Probe
• 00816589020731: 2.2mm Diffusing Tip Laser Probe
• 00816589020717: 2.2mm Diffusing Tip Laser Probe
• 00816589020700: 2.2mm Diffusing Tip Laser Probe
• 00816589020519: 2.2mm Diffusing Tip Laser Probe
• 00816589020502: 2.2mm Diffusing Tip Laser Probe
• 00816589020496: 2.2mm Diffusing Tip Laser Probe
• 00816589020489: 2.2mm Diffusing Tip Laser Probe
• 00816589020472: 2.2mm Diffusing Tip Laser Probe
• 00816589020465: 2.2mm Diffusing Tip Laser Probe
• 00816589020427: 2.2mm Diffusing Tip Laser Probe
• 00816589020304: 2.2mm Diffusing Tip Laser Probe
• 00816589020298: 2.2mm Diffusing Tip Laser Probe
• 00816589020281: 2.2mm Diffusing Tip Laser Probe
• 00816589020274: 2.2mm Diffusing Tip Laser Probe
• 00816589020267: 2.2mm Diffusing Tip Laser Probe
• 00816589020250: 2.2mm Diffusing Tip Laser Probe
• 00816589020243: 2.2mm Diffusing Tip Laser Probe