FDA.reportPublic FDA data

SurgiSight™ Digital Visualization System

Primary DI
00860011130741
Brand
SurgiSight™ Digital Visualization System
Company
Unify Medical Inc.
Model
SGS-001
Device description
Syspack, Wired Controller, Headset Cable, and Belt
Published
2025-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSOMICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSOMicroscope, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011130741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011130741008600111307418600111307410860011130741

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical microscopeA general-purpose, surgical, light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures, e.g., nerves or vessels in the performance of delicate surgical procedures which require high magnification by transmitted light. An operating microscope will often be equipped with motorized focusing, adjustable magnification mechanisms (manual, zoom or both), backup lamps, and inclined tubes that permit the surgeon to see the field from a vertical perspective while keeping the head erect. Dual or multiple observation capability and the optical integration of still, motion picture and video cameras are common features. It can be fixed or mobile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117471657
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011130734SurgiSight™ Digital Visualization HeadsetSGS-1002025-12-02
00860011130703Amplio™ Digital Visualization SystemAMP-0012023-12-19
00860011130710Amplio™ Digital Visualization HeadsetAMP-1002023-12-19
00860011130727Amplio™ Digital Visualization System KitAMP-0012023-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811608019970Mounting Kit, for Kaps SOM62VOLK OPTICAL INC.FSO2026-04-27
00811608019987ROLS Adapter Kit, for KapsVOLK OPTICAL INC.FSO2026-04-27
00860011130734SurgiSight™ Digital Visualization HeadsetUnify Medical Inc.FSO2025-12-02
06945095524779zumaxZumax Medical Co., LTDFSO2025-10-28
06945095524991zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525097zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525134zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525462zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525486zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525493zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525523zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525530zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525561zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525578zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525660zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525677zumaxZumax Medical Co., LTDFSO2025-10-28
06945095525745zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526186zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526254zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526261zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526322zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526339zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526360zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526421zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526476zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526513zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526544zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526568zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526575zumaxZumax Medical Co., LTDFSO2025-10-28
06945095526582zumaxZumax Medical Co., LTDFSO2025-10-28