FDA.reportPublic FDA data

VISERA Pro XENON LIGHT SOURCE

Primary DI
04953170228933
Brand
VISERA Pro XENON LIGHT SOURCE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OLYMPUS CLV-S40Pro
Device description
CLV-S40PRO CLV-S40 PRO 300W VISERA PRO X
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
NWBEndoscope, accessories, narrow band spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062049000EVIS EXERA II 180 SYSTEMOlympus Medical Systems Corporation2006-09-22NWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170228933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170228933049531702289334953170228933

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source, line-poweredA mains electricity (AC-powered), typically bench-top unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., arthroscopes, cystoscopes, laparoscopes, gastroscopes). It provides a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

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
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
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410513790FUJIFILMFUJIFILM CORPORATIONNWB2025-05-31
04953170423628GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2025-05-26
07613327616682SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616699SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616705SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616712SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616729SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616743SPYSTRYKER CORPORATIONNWB2024-02-27
076133276089151788STRYKER CORPORATIONNWB2023-12-11
04953170414596EVIS X1 VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
0495317041560912G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
0495317041562312G-SDI cableOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
0495317041563012G-SDI cable 8.5MOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
049531704156473G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170415654Foot holderOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170415685Footswitch Conversion cableOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170420191GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170424281COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170411526RHINO-LARYNGO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-24
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170338496VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170386015VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170386060VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170026324KEY BOARDOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-16
04547410446081FUJIFILMFUJIFILM CORPORATIONNWB2021-09-29
04547410446104FUJIFILMFUJIFILM CORPORATIONNWB2021-09-29
04953170409820CONNECTING TUBEOLYMPUS MEDICAL SYSTEMS CORP.NWB2020-12-15
04953170416132EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2020-08-27
04953170420702EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2020-08-27
04042761083485OlympusOLYMPUS Winter & Ibe GmbHNWB2020-07-31