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
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