FDA.reportPublic FDA data

MaxView System - Lateral Set

Primary DI
00850007069353
Brand
MaxView System - Lateral Set
Company
VISEON, INC.
Model
MAX-02
Device description
MaxView System - Lateral Set Gen 2, Long
Published
2024-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
00850007069353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850007069353008500070693538500070693530850007069353

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
096680671
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007069650MISScope 4KVSY-18502024-02-06
00850007069407Imager Adaptor for NuVasive® MaXcess® 4 RetractorNUX-S2024-02-05
00850007069414Imager Adaptor for Globus Mars™3VL RetractorGLO-S2024-02-05
00850007069421Imager Adaptor for Alphatec PTP™ RetractorATC-S2024-02-05
00850007069476Imager Adaptor for Stryker Niagra® RetractorSKN-S2024-02-05
00850007069599Imager Adaptor for Medtronic® OLIF25 RetractorMDT-S2024-02-05
00850007069605Imager Adaptor for TeDan Phantom XL3™ RetractorTD3-S2024-02-05
00850007069612Imager Adaptor for SeaSpine® Lattus RetractorLTS-S2024-02-05
00850007069636Imager Adaptor for Medtronic® OLIF51 RetractorM51-S2024-02-05
00850007069346MaxView System - Lateral SetMAX-012024-02-05
00850007069360Imager Adaptor for NuVasive® MaXcess® 4 RetractorNUX-S2024-02-05
00850007069377Imager Adaptor for Globus Mars™3VL RetractorGLO-S2024-02-05
00850007069391Imager Adaptor for Alphatec PTP™ RetractorATC-S2024-02-05
00850007069445Image Control BoxICB-4K2024-02-05
00850007069438Imager Adaptor for Stryker Niagra® RetractorSKN-S2024-02-05
00850007069483MaxView 4K, Lateral ImagerMAX-L102024-02-05
00850007069490MaxView 4K, Lateral ImagerMAX-L202024-02-05
00850007069452Imager Adaptor for Medtronic® OLIF25 RetractorMDT-S2024-02-05
00850007069469Imager Adaptor for TeDan Phantom XL3™ RetractorTD3-S2024-02-05
00850007069582Imager Adaptor for SeaSpine® Lattus RetractorLTS-S2024-02-05

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
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00860011130741SurgiSight™ Digital Visualization SystemUnify Medical Inc.FSO2025-12-02
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