ClearPoint Inflexion Avanto Head Fixation Frame CP-INHFF-112-01

GUDID 00850376007482

Inflexion Head Fixation Frame Fits Siemens Avanto / Espree / Symphony / Sonata / Verio / Trio Scanner Tables

CLEARPOINT NEURO, INC.

Stereotactic radiosurgical invasive head frame
Primary Device ID00850376007482
NIH Device Record Key1fa64867-0ea9-4a56-943e-8d1a723dbb7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearPoint Inflexion Avanto Head Fixation Frame
Version Model NumberCP-INHFF-112-01
Catalog NumberCP-INHFF-112-01
Company DUNS959181160
Company NameCLEARPOINT NEURO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailinfo@mriinterventions.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com
Phone949-900-6833
Emailquality@clearpointneuro.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850376007482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBLHolder, Head, Neurosurgical (Skull Clamp)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-01
Device Publish Date2021-01-22

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

08503760070488Inflexion Head Fixation Frame Fits Siemens Avanto / Espree / Symphony / Sonata / Verio / Trio Sc
00850376007482Inflexion Head Fixation Frame Fits Siemens Avanto / Espree / Symphony / Sonata / Verio / Trio Sc

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.