FDA.reportPublic FDA data

ORBEYE SURGICAL MICROSCOPE

Primary DI
04953170395871
Brand
ORBEYE SURGICAL MICROSCOPE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OME-V200
Published
2017-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPTMICROSCOPE, SURGICAL
IZISystem, X-Ray, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPTMicroscope, SurgicalGeneral, Plastic Surgery1
IZISystem, X-Ray, AngiographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190772000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190772000SURGICAL MICROSCOPE SYSTEM ORBEYE with IROlympus Medical Systems Corp.2019-10-10IZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170395871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170395871049531703958714953170395871

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical microscopeA general-purpose, surgical 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120548Alpine Stirrups, Metric, LeftQfixIZI2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixIZI2026-04-14
00841962120388Lumen AirShuttleQfixIZI2025-12-02
07630003501421M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501629M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501636M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
07630003501643M320 Optics CarrierLeica Microsystems (Schweiz) AGEPT2025-10-22
08600105136202RE3Digital Surgery Systems, Inc.IZI2025-07-15
00840183528461BR Surgical, LLCBR Surgical, LLCEPT2024-11-07
00850047802002Prescott’s Wall Mount Surgical Microscope PlatformPrescott's Inc.EPT2024-02-22
00850047802019 OSM200 StandPrescott's Inc.EPT2024-02-22
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 AirShuttleâ„¢QfixIZI2023-04-10
00860009669147SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-13
00860009669154SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-13
00860009669161SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-13
00860009669109SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-12
00860009669116SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-12
00860009669123SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-12
00860009669130SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDEPT2022-12-12
U1OM200WLRX1MICROSCOPEEclerisEPT2022-07-29
U1OM200WRX1MICROSCOPEEclerisEPT2022-07-18