FDA.reportPublic FDA data

Medical Microscope

Primary DI
06970873260181
Brand
Medical Microscope
Company
DENJOY DENTAL CO.,LTD
Model
iX8
Published
2022-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
06970873260181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970873260181069708732601816970873260181

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
529329650
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
06979865810007Integrated Endo SystemMeet Endo-II2026-03-31
06979865810014Gutta Percha CutterMeta Pack2026-03-31
06970873260389Integrated Endo System Meet Endo-II2025-02-28
06970873260297Root Canal Instruments KitDY21-12022-02-19
06970873260013PULP TESTERDY3102022-02-19
06970873260051Endo Motor RCTI-DY(II)2022-02-19
06970873260068Endo Motor iMate-II2022-02-19
06970873260075Endo Motor iMate-II(IM2C)2022-02-19
06970873260082Cordless Gutta percha obturation system DY-GP2022-02-19
06970873260112Endo Rotary file K file, Machine super file, Machine H file, G file2022-02-19
06970873260143Gutta percha obturation system DY-GP Plus2022-02-19
06970873260167Medical MicroscopeiX62022-02-19
06970873260174Medical MicroscopeiX72022-02-19
06970873260198Endo Motor Ai Mate-I2022-02-19
06970873260259Endo Motor Ai Mate-II2022-02-19
06970873260266Endo Motor iMate 32022-02-19
06970873260280Medical Face ShieldDF-202022-02-19
06970873260303 Dental Suction UnitDY-CX012022-02-19
06970873260310Intraoral CameraOrdinary model, standard model, luxury model2022-02-19
06970873260327Pulp Canal ReamerVertical pressure needle2022-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906168451499Prima Lite Surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451505Prima Lite Surgical Microscope Wall mountLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451512Prima Lite ENT Surgical MicroscopesLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451529Prima Lite trainerLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451536Prima Swift surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451543Prima Pro surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451550Prima Pro surgical MicroscopeLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
08906168451567Prima Floor Stand with ColumnLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDFSO2026-07-19
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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
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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