FDA.reportPublic FDA data

EVIS EXERA II DUODENOVIDEOSCOPE

Primary DI
04953170229503
Brand
EVIS EXERA II DUODENOVIDEOSCOPE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
TJF-Q180V
Published
2016-09-21
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
FDTduodenoscope and accessories, flexible/rigid
NWBEndoscope, accessories, narrow band spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDTDuodenoscope And Accessories, Flexible/RigidGastroenterology, Urology2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143153000EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180VOlympus Medical Systems Corp.2016-01-15FDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170229503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170229503049531702295034953170229503

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video duodenoscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine). It is inserted into the body through the mouth during duodenoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used to examine structures and mucous membranes of the duodenum for conditions like ulcers, polyps, and cancer. This is a reusable device.

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
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170459207Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8019N62211302025-12-02
04953170459252Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8022N62213302025-12-02
04953170459313Single-use Fine Needle Biopsy (FNB) DeviceNA-U210H-8025N62215302025-12-02
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327616699SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616705SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616712SPYSTRYKER CORPORATIONNWB2024-02-27
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07613327616743SPYSTRYKER CORPORATIONNWB2024-02-27
076133276089151788STRYKER CORPORATIONNWB2023-12-11
14961333232960PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333232991PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333246233PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04953170063749EYEPIECE CAPOLYMPUS MEDICAL SYSTEMS CORP.FDT2021-12-20
04953170064012LIGHTGUIDE CAPOLYMPUS MEDICAL SYSTEMS CORP.FDT2021-12-20
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170338496VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170026324KEY BOARDOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-16
04547410446081FUJIFILMFUJIFILM CORPORATIONNWB2021-09-29
04547410446104FUJIFILMFUJIFILM CORPORATIONNWB2021-09-29
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04547410384543FUJIFILMFUJIFILM CORPORATIONNWB2020-07-20
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08714729983514EXALT™ Model DBOSTON SCIENTIFIC CORPORATIONFDT2019-12-23
B747EAI0496EndochEndoch IncNWB2019-10-01
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