neuroinspire

GUDID 05057078000024

neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures.

RENISHAW P L C

Image segmentation application software

• Primary Device ID: 05057078000024
• NIH Device Record Key: a355a502-2289-4acb-af1a-1b5f3063ae4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neuroinspire
• Version Model Number: A-5630-3008
• Company DUNS: 217226935
• Company Name: RENISHAW P L C
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05057078000024 [Primary]
GS1	15057078000021 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163666

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-25
• Device Publish Date: 2019-11-15

Devices Manufactured by RENISHAW P L C

• 05057078000024 - neuroinspire: 2019-11-25neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures.
• 05057078000024 - neuroinspire: 2019-11-25 neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neuro
• 05057078000031 - Ti DG1: 2019-01-18 Titanium Powder Ti6-4-GD23
• 05057078000017 - Ti DG1: 2018-04-20 Titanium Powder Ti6-4-GD23