SmartFrame NGS-AK-01-11

GUDID 00850359007015

SMARTFrame Accessory Kit

MRI INTERVENTIONS, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00850359007015
• NIH Device Record Key: b0f20a53-1d36-472e-954f-624a4ab373ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartFrame
• Version Model Number: NGS-AK-01-11
• Catalog Number: NGS-AK-01-11
• Company DUNS: 959181160
• Company Name: MRI INTERVENTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: 949-900-6833
• Email: info@mriinterventions.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850359007015 [Primary]

FDA Product Code

• ORR: Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-12

On-Brand Devices [SmartFrame]

• 00850359007041: SMARTFrame Scalp Mount Rescue Screw- Short
• 00850359007040: SMARTFrame Scalp Mount Rescue Screw - Long
• 00850359007039: SMARTFrame Skull Mount Rescue Screw
• 00850359007038: SMARTFrame Wharen Centering Guide
• 00850359007033: SmartFrame® Skull Mount Base
• 00850359007032: SMARTFrame Scalp Mount Base
• 00850359007031: SmartFrame® XG Exchangeable Device Guide, 4.5-mm
• 00850359007030: SMARTFrame XG Exchangeable Device Guides
• 00850359007028: SMARTFrame Guide Tubes .074” / 15 ga
• 00850359007027: SMARTFrame Guide Tubes .068” / 16 ga
• 00850359007026: SMARTFrame Guide Tubes .064” / CP Stylet
• 00850359007025: SMARTFrame Guide Tubes .060” / 17 ga
• 00850359007024: SMARTFrame Guide Tubes .052” / 18 ga
• 00850359007023: SMARTFrame Guide Tubes
• 00850359007017: SMARTFrame Thumb Wheel Extension Set
• 00850359007016: SMARTFrame Hand Controller
• 00850359007015: SMARTFrame Accessory Kit
• 00850359007013: SMARTFrame MRI-Guided Trajectory Tower w/o Base
• 00850359007012: SMARTFrame XG MRI-Guided Trajectory Frame
• 00850359007011: SMARTFrame MRI-Guided Trajectory Frame
• 00850359007010: SMARTFrame XG 4.5 w/ Wharen Centering Guide and TE
• 00850359007009: SMARTFrame XG 4.5 TwistPoint Kit w/ TE
• 00850359007008: SMARTFrame XG 4.5 TwistPoint Kit w/ HC
• 00850359007007: SMARTFrame XG TwistPoint Kit w/ HC - E
• 00850359007005: SMARTFrame XG TwistPoint Kit w/ HC
• 00850359007004: SMARTFrame Scalp Mount Kit w/ TE
• 00850359007003: SMARTFrame Scalp Mount Kit w/ HC
• 00850359007002: SMARTFrame Kit w/ TE
• 00850359007001: SMARTFrame Kit w/ HC