FDA.reportPublic FDA data

SurgiSight™ Digital Visualization Headset

Primary DI
00860011130734
Brand
SurgiSight™ Digital Visualization Headset
Company
Unify Medical Inc.
Model
SGS-100
Device description
Visualization Headset
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
00860011130734PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011130734008600111307348600111307340860011130734

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
00860011130741SurgiSight™ Digital Visualization SystemSGS-0012025-12-02
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
06945095527749zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527756zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527763zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527787zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527794zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527817zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527848zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527879zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527886zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527893zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527909zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527916zumaxZumax Medical Co., LTDFSO2026-07-06
06945095527954zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528005zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528012zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528029zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528036zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528043zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528050zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528067zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528074zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528081zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528166zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528197zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528487zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528500zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528517zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528548zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528562zumaxZumax Medical Co., LTDFSO2026-07-06
06945095528579zumaxZumax Medical Co., LTDFSO2026-07-06