Modus IR

GUDID 00670082000603

Surgical Exoscope Fluorescence Filter

Synaptive Medical Inc

Surgical microscope fluorescent angiography system
Primary Device ID00670082000603
NIH Device Record Keyd80bed43-3da4-4636-a41b-0cf5ecc42f90
Commercial Distribution StatusIn Commercial Distribution
Brand NameModus IR
Version Model NumberSYN-0990
Company DUNS203061833
Company NameSynaptive Medical Inc
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com
Phone844-462-7246
Emailservice@synaptivemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100670082000603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZISystem, X-Ray, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-10
Device Publish Date2024-04-02

Devices Manufactured by Synaptive Medical Inc

00670082000252 - Multi-Tool Calibration Device2025-06-23
00670082000269 - Short Pointer2025-06-23
00670082000351 - Sterilizable Storage Tray2025-06-23
00670082000467 - Modus V2025-06-23 Robotic Digital Microscope
00670082000474 - Modus V2025-06-23 Robotic Digital Microscope
00670082000504 - Modus Nav Software2025-06-23
00670082000528 - Modus Nav Operator Cart2025-06-23
00670082000535 - Long Pointer2025-06-23

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