FDA.reportPublic FDA data

Video Coupler

Primary DI
04953170028465
Brand
Video Coupler
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OLYMPUS MH-999E
Catalog number
5705130
Device description
"""MH-999E COUPLER OTV-S5 EYEPIEC"""
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)
EOQBronchoscope (Flexible Or Rigid)
FAJCystoscope And Accessories, Flexible/Rigid
FCLForceps, Biopsy, Non-Electric
FDFColonoscope And Accessories, Flexible/Rigid
FDISnare, Flexible
FDSGastroscope And Accessories, Flexible/Rigid
FGAKit, Nephroscope
FGBUreteroscope And Accessories, Flexible/Rigid
GCJLaparoscope, general & plastic surgery
HETLaparoscope, Gynecologic (And Accessories)
KGEForceps, Biopsy, Electric
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
NWBEndoscope, Accessories, Narrow Band Spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FDISnare, FlexibleGastroenterology, Urology2
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
FGAKit, NephroscopeGastroenterology, Urology2
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2
KGEForceps, Biopsy, ElectricGastroenterology, Urology2
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955404000OTV-S5 OES VIDEO SYSTEMOlympus America, Inc.1996-02-01GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170028465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170028465049531700284654953170028465

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitA mains electricity (AC-powered) device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Ethylene Oxide""]"
High-level Disinfectant;Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
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

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