SRP BrainStorm

GUDID 00860003884119

SuRgical Planner (SRP) BrainStorm Desktop System

SURGICAL THEATER LLC

Surgical simulation system

• Primary Device ID: 00860003884119
• NIH Device Record Key: 078cef4f-1d6d-4102-b2cc-2e39528aff74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SRP BrainStorm
• Version Model Number: BrainStorm
• Company DUNS: 071341647
• Company Name: SURGICAL THEATER LLC
• 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: 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: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net
• Phone: 216-452-2177
• Email: information@surgicaltheater.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003884119 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201465

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2020-12-16
• Device Publish Date: 2020-12-08

Devices Manufactured by SURGICAL THEATER LLC

• 00860003884126 - SpineAR SNAP: 2023-07-03 SpineAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
• 00860003884102 - SyncAR SNAP: 2023-06-26 SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
• 00860003884119 - SRP BrainStorm: 2020-12-16SuRgical Planner (SRP) BrainStorm Desktop System
• 00860003884119 - SRP BrainStorm: 2020-12-16 SuRgical Planner (SRP) BrainStorm Desktop System
• 00863157000305 - SNAP OR: 2019-12-16 Surgical Navigation Advanced Platform (SNAP) Operating Room System
• 00863157000312 - SNAP Desktop: 2018-07-06 Surgical Navigation Advanced Platform (SNAP) Desktop System
• 00863157000329 - Endo SNAP: 2018-07-06 Endoscope Surgical Navigation Advanced Platform (SNAP) Operating Room System
• 00863157000336 - SRP: 2018-07-06 SuRgical Planner (SRP) Desktop System
• 00863157000343 - Notebook Clinic Viewer: 2018-07-06 SuRgical Planner (SRP) Clinic Viewer Notebook