ClearPoint Inflexion IMRIS Head Fixation Frame CP-INHFF-232-01

GUDID 08503760070501

Inflexion Head Fixation Frame fits IMRIS surgical tables

CLEARPOINT NEURO, INC.

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 08503760070501
• NIH Device Record Key: 6a0593e7-b06d-4d86-9bc8-e1b53405fa33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearPoint Inflexion IMRIS Head Fixation Frame
• Version Model Number: CP-INHFF-232-01
• Catalog Number: CP-INHFF-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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08503760070501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191701

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: 2
• Public Version Date: 2020-03-12
• Device Publish Date: 2020-01-29

On-Brand Devices [ClearPoint Inflexion IMRIS Head Fixation Frame]

• 08503760070501: Inflexion Head Fixation Frame fits IMRIS surgical tables
• 00850376007505: Inflexion Head Fixation Frame fits IMRIS surgical tables