ClearPoint CP-MPHFF-232-01

GUDID 08503760070426

ClearPoint ® IMRIS Universal Multi-Positional Head Fixation Frame

CLEARPOINT NEURO, INC.

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 08503760070426
• NIH Device Record Key: cc245ba7-a87d-4501-84e8-d1043f41f33e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearPoint
• Version Model Number: CP-MPHFF-232-01
• Catalog Number: CP-MPHFF-232-01
• Company DUNS: 959181160
• Company Name: CLEARPOINT NEURO, 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	08503760070426 [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: 5
• Public Version Date: 2020-03-12
• Device Publish Date: 2016-09-24

On-Brand Devices [ClearPoint]

• 08503760070464: ClearPoint IMRIS Aera-Skyra Multi-Positional Head Fixation Frame
• 08503760070457: ClearPoint IMRIS Aera-Skyra Head Fixation Frame
• 08503760070440: ClearPoint IMRIS ORT 400 Table Extension
• 08503760070433: ClearPoint IMRIS Table Stabilizer - Aera/Skyra
• 08503760070426: ClearPoint ® IMRIS Universal Multi-Positional Head Fixation Frame
• 08503760070419: ClearPoint ® IMRIS Universal Head Fixation Frame
• 08503760070402: GE Housing Cover
• 08503760070396: ClearPoint Multi-Positional Lower HFF Screws for Philips
• 08503760070389: ClearPoint Multi-Positional Lower HFF Screws for GE, Siemens and IMRIS
• 08503760070372: ClearPoint Multi-Positional Upper Fixation Frame Screws
• 08503760070365: ClearPoint GE Compatible Fixation Frame Screws
• 08503760070358: ClearPoint Fixation Frame Screws, Philips
• 08503760070341: ClearPoint Fixation Frame Screws
• 08503760070334: ClearPoint Multi-Positional HFF/Table Mounts for Philips Ingenia
• 08503760070327: ClearPoint Multi-Positional HFF/Table Mounts for Philips Achieva
• 08503760070310: ClearPoint Multi-Positional HFF/Table Mounts for GE 750W
• 08503760070303: ClearPoint Multi-Positional HFF/Table Mounts for GE HDw (450w) Table
• 08503760070297: ClearPoint Multi-Positional HFF/Table Mounts for GE HDx Table
• 08503760070280: ClearPoint Multi-Positional HF/Table Mounts for IMRIS with ORT 200 Table
• 08503760070273: ClearPoint Multi-Positional HF/Table Mounts for IMRIS with ORT 100 Table
• 08503760070266: ClearPoint Multi-Positional HFF/Table Mounts for IMRIS with Base
• 08503760070259: ClearPoint Multi-Positional HF/Table Mounts for Siemens Aera/Skyra
• 08503760070242: ClearPoint Multi-Positional HFF/Table Mounts for Siemens Avanto/Espree/Symphony/Sonata
• 08503760070235: ClearPoint Adjustable Table Mount, Philips Ingenia - DORO
• 08503760070228: ClearPoint Adjustable Table Mount, Philips Achieva -DORO
• 08503760070211: ClearPoint Adjustable Table Mount, GE 750w-Integra
• 08503760070204: ClearPoint Adjustable Table Mount, GE 450w (HDw)-Integra
• 08503760070198: ClearPoint Adjustable Table Mount, GE HDx-Integra
• 08503760070181: ClearPoint® Adjustable Table Mount, IMRIS - Integra
• 08503760070174: ClearPoint® Adjustable Table Mount, IMRIS - DORO
• 08503760070167: ClearPoint® Adjustable Table Mount, SMS Aera/Skyra - DORO
• 08503760070150: ClearPoint® Adjustable Table Mount, SMS Avanto - DORO
• 08503760070143: ClearPoint Philips Ingenia Table Head Fixation Frame
• 08503760070136: ClearPoint Philips Achieva Table Head Fixation Frame
• 08503760070129: ClearPoint® GE 750w Table Head Fixation Frame
• 08503760070112: ClearPoint GE HDw (450w) Table Head Fixation Frame
• 08503760070105: ClearPoint GE HDx Table Head Fixation Frame
• 08503760070099: ClearPoint IMRIS Stabilizer Ramp
• 08503760070082: ClearPoint IMRIS Table Stabilizer
• 08503760070075: ClearPoint IMRIS ORT 200 Table Extension
• 08503760070068: ClearPoint® IMRIS ORT 200 Head Fixation Frame
• 08503760070051: ClearPoint® IMRIS ORT 100 Head Fixation Frame
• 08503760070044: ClearPoint IMRIS T –Series Table Head Fixation Frame/Base
• 08503760070037: ClearPoint® Siemens Aera/Skyra Table Head Fixation Frame
• 08503760070020: ClearPoint® Siemens Avanto/Espree/ Symphony/Sonata Table HFF
• 08503760070013: ClearPoint SMS Avanto/Espree/ Symphony/Sonata Table HFF/Base
• 08503590070665: SmartFrame XG Burr Hole Kit with Skull Mount
• 08503590070658: SmartFrame XG TwistPoint Kit 4.5 and 3.4 Bits - No Hand Drill
• 08503590070641: SmartFrame XG TwistPoint Kit 4.5 and 3.4 Bits and Hand Drill
• 08503590070634: SmartFrame Burr Hole Kit with Scalp Mount