SyncAR SNAP

GUDID 00860003884102

SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System

SURGICAL THEATER LLC

Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system
Primary Device ID00860003884102
NIH Device Record Key8c063ec6-0df5-432f-9607-5ddbd39f0319
Commercial Distribution StatusIn Commercial Distribution
Brand NameSyncAR SNAP
Version Model NumberSyncAR
Company DUNS071341647
Company NameSURGICAL THEATER LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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

Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com
Phone330-472-6520
Emailinformation@surgicaltheater.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003884102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-06-26
Device Publish Date2020-06-01

Devices Manufactured by SURGICAL THEATER LLC

00860003884126 - SpineAR SNAP2023-07-03 SpineAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
00860003884102 - SyncAR SNAP2023-06-26SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
00860003884102 - SyncAR SNAP2023-06-26 SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
00860003884119 - SRP BrainStorm2020-12-16 SuRgical Planner (SRP) BrainStorm Desktop System
00863157000305 - SNAP OR2019-12-16 Surgical Navigation Advanced Platform (SNAP) Operating Room System
00863157000312 - SNAP Desktop2018-07-06 Surgical Navigation Advanced Platform (SNAP) Desktop System
00863157000329 - Endo SNAP2018-07-06 Endoscope Surgical Navigation Advanced Platform (SNAP) Operating Room System
00863157000336 - SRP2018-07-06 SuRgical Planner (SRP) Desktop System
00863157000343 - Notebook Clinic Viewer2018-07-06 SuRgical Planner (SRP) Clinic Viewer Notebook
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