ClearPoint CP- MPHFF-312-01

GUDID 00850376007029

ClearPoint Multi-Positional HFF/Table Mounts for GE HDx Table

MRI INTERVENTIONS, INC.

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 00850376007029
• NIH Device Record Key: 3b766594-e940-41bc-8df3-bbf057ddc502
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearPoint
• Version Model Number: CP- MPHFF-312-01
• Catalog Number: CP- MPHFF-312-01
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: 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	00850376007029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091439

FDA Product Code

• HBL: Holder, Head, Neurosurgical (Skull Clamp)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-12

On-Brand Devices [ClearPoint]

• 00850376007046: ClearPoint IMRIS Aera-Skyra Multi-Positional Head Fixation Frame
• 00850376007045: ClearPoint IMRIS Aera-Skyra Head Fixation Frame
• 00850376007044: ClearPoint IMRIS ORT 400 Table Extension
• 00850376007043: ClearPoint IMRIS Table Stabilizer - Aera/Skyra
• 00850376007042: ClearPoint ® IMRIS Universal Multi-Positional Head Fixation Frame
• 00850376007041: ClearPoint ® IMRIS Universal Head Fixation Frame
• 00850376007040: GE Housing Cover
• 00850376007039: ClearPoint Multi-Positional Lower HFF Screws for Philips
• 00850376007038: ClearPoint Multi-Positional Lower HFF Screws for GE, Siemens and IMRIS
• 00850376007037: ClearPoint Multi-Positional Upper Fixation Frame Screws
• 00850376007036: ClearPoint GE Compatible Fixation Frame Screws
• 00850376007035: ClearPoint Fixation Frame Screws, Philips
• 00850376007034: ClearPoint Fixation Frame Screws
• 00850376007033: ClearPoint Multi-Positional HFF/Table Mounts for Philips Ingenia
• 00850376007032: ClearPoint Multi-Positional HFF/Table Mounts for Philips Achieva
• 00850376007031: ClearPoint Multi-Positional HFF/Table Mounts for GE 750W
• 00850376007030: ClearPoint Multi-Positional HFF/Table Mounts for GE HDw (450w) Table
• 00850376007029: ClearPoint Multi-Positional HFF/Table Mounts for GE HDx Table
• 00850376007028: ClearPoint Multi-Positional HF/Table Mounts for IMRIS with ORT 200 Table
• 00850376007027: ClearPoint Multi-Positional HF/Table Mounts for IMRIS with ORT 100 Table
• 00850376007026: ClearPoint Multi-Positional HFF/Table Mounts for IMRIS with Base
• 00850376007025: ClearPoint Multi-Positional HF/Table Mounts for Siemens Aera/Skyra
• 00850376007024: ClearPoint Multi-Positional HFF/Table Mounts for Siemens Avanto/Espree/Symphony/Sonata
• 00850376007023: ClearPoint Adjustable Table Mount, Philips Ingenia - DORO
• 00850376007022: ClearPoint Adjustable Table Mount, Philips Achieva -DORO
• 00850376007021: ClearPoint Adjustable Table Mount, GE 750w-Integra
• 00850376007020: ClearPoint Adjustable Table Mount, GE 450w (HDw)-Integra
• 00850376007019: ClearPoint Adjustable Table Mount, GE HDx-Integra
• 00850376007018: ClearPoint® Adjustable Table Mount, IMRIS - Integra
• 00850376007017: ClearPoint® Adjustable Table Mount, IMRIS - DORO
• 00850376007016: ClearPoint® Adjustable Table Mount, SMS Aera/Skyra - DORO
• 00850376007015: ClearPoint® Adjustable Table Mount, SMS Avanto - DORO
• 00850376007014: ClearPoint Philips Ingenia Table Head Fixation Frame
• 00850376007013: ClearPoint Philips Achieva Table Head Fixation Frame
• 00850376007012: ClearPoint® GE 750w Table Head Fixation Frame
• 00850376007011: ClearPoint GE HDw (450w) Table Head Fixation Frame
• 00850376007010: ClearPoint GE HDx Table Head Fixation Frame
• 00850376007009: ClearPoint IMRIS Stabilizer Ramp
• 00850376007008: ClearPoint IMRIS Table Stabilizer
• 00850376007007: ClearPoint IMRIS ORT 200 Table Extension
• 00850376007006: ClearPoint® IMRIS ORT 200 Head Fixation Frame
• 00850376007005: ClearPoint® IMRIS ORT 100 Head Fixation Frame
• 00850376007004: ClearPoint IMRIS T –Series Table Head Fixation Frame/Base
• 00850376007003: ClearPoint® Siemens Aera/Skyra Table Head Fixation Frame
• 00850376007002: ClearPoint® Siemens Avanto/Espree/ Symphony/Sonata Table HFF
• 00850376007001: ClearPoint SMS Avanto/Espree/ Symphony/Sonata Table HFF/Base
• 00850359007066: SmartFrame XG Burr Hole Kit with Skull Mount
• 00850359007065: SmartFrame XG TwistPoint Kit 4.5 and 3.4 Bits - No Hand Drill
• 00850359007064: SmartFrame XG TwistPoint Kit 4.5 and 3.4 Bits and Hand Drill
• 00850359007063: SmartFrame Burr Hole Kit with Scalp Mount