FDA.reportPublic FDA data

RE3

Primary DI
08600105136202
Brand
RE3
Company
Digital Surgery Systems, Inc.
Model
5900-0208
Device description
RE3 robotic excoscope system and accessories.
Published
2025-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
FSOMicroscope, Surgical, General & Plastic Surgery
IZISystem, X-Ray, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSOMicroscope, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
IZISystem, X-Ray, AngiographicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08600105136202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08600105136202086001051362028600105136202

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical microscopeA light (optical) magnification instrument, usually stereoscopic, designed to magnify minute structures within the neurological fields for surgery, typically the brain or spine or surroundings in the performance of neurological surgical procedures which require high magnification by transmitted light. It 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 is usually fixed.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
095204175
Device count
1
Premarket exempt
true
Kit
true
Serial number
true

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
00841962120548Alpine Stirrups, Metric, LeftQfixIZI2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixIZI2026-04-14
00841962120388Lumen AirShuttleQfixIZI2025-12-02
00850007069407Imager Adaptor for NuVasive® MaXcess® 4 RetractorVISEON, INC.FSO2024-02-05
00850007069414Imager Adaptor for Globus Mars™3VL RetractorVISEON, INC.FSO2024-02-05
00850007069421Imager Adaptor for Alphatec PTP™ RetractorVISEON, INC.FSO2024-02-05
00850007069476Imager Adaptor for Stryker Niagra® RetractorVISEON, INC.FSO2024-02-05
00850007069599Imager Adaptor for Medtronic® OLIF25 RetractorVISEON, INC.FSO2024-02-05
00850007069605Imager Adaptor for TeDan Phantom XL3™ RetractorVISEON, INC.FSO2024-02-05
00850007069612Imager Adaptor for SeaSpine® Lattus RetractorVISEON, INC.FSO2024-02-05
00850007069636Imager Adaptor for Medtronic® OLIF51 RetractorVISEON, INC.FSO2024-02-05
10193489068184NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068191NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068207NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
00195278719263AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719577AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719720AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719744AlliaGE MEDICAL SYSTEMSIZI2023-12-08
10193489068092MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10193489140170MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10841962118733Iris AirShuttle™QfixIZI2023-04-10
00195278485144AlliaGE MEDICAL SYSTEMSIZI2022-04-13
00195278485168AlliaGE MEDICAL SYSTEMSIZI2022-04-08
00860001790290SterimedSTERIMED LLCIZI2021-09-29
00860007655609SterimedSTERIMED LLCIZI2021-09-29
10193489058826NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489058833NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059038NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26