FDA.reportPublic FDA data

Olympus

Primary DI
04042761069663
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
WA96100A
Published
2023-06-20
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
EQLLaryngostroboscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQLLaryngostroboscopeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042761069663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042761069663040427610696634042761069663

GMDN Terms#

Term, Definition table
TermDefinition
Rigid rhinoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasal cavity and/or nasopharynx. It is inserted into the body through a nostril or the oral cavity during rhinoscopy or an ear/nose/throat (ENT) intervention. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. Also referred to as a nasoscope or nasal endoscope, it is commonly used during the removal of the adenoids (glandular tissue in the nasopharynx, also known as the pharyngeal tonsils). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
316957240
Device count
1
Premarket 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
04042761082297OlympusWA03300AWA03300A2016-09-22
04042761082303OlympusWA03310AWA03310A2016-09-22
14042761083369OlympusWT645010WT6450102023-06-20
04042761083324OlympusWT806450WT8064502023-01-27
04042761081757OlympusWA97013AWA97013A2023-06-20
04042761083102OlympusWT2187002023-06-20
04042761083119OlympusWT2187052023-06-20
04042761083126OlympusWT2187112023-06-20
04042761083133OlympusWT2187202023-06-20
04042761083140OlympusWT6304002023-06-20
04042761083164OlympusWT6400212023-06-20
04042761083171OlympusWT645001WT6450012023-06-20
04042761083188OlympusWT645006WT6450062023-06-20
04042761083218OlympusWT645013WT6450132023-06-20
04042761083225OlympusWT645016WT6450162023-06-20
04042761083232OlympusWT645017WT6450172023-06-20
04042761083256OlympusWT645020WT6450202023-06-20
04042761083263OlympusWT645025WT6450252023-06-20
04042761083270OlympusWT645030WT6450302023-06-20
04042761083287OlympusWT645031WT6450312023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333255733PENTAX Medical Laryngeal StroboscopePENTAX OF AMERICA, INC.EQL2025-10-06
04961333255740PENTAX Medical Rigid LaryngostroboscopesPENTAX OF AMERICA, INC.EQL2025-10-03
04961333255016LARYNGOSTROBOSCOPEPENTAX OF AMERICA, INC.EQL2025-04-25
04961333255702LARYNGOSTROBOSCOPEPENTAX OF AMERICA, INC.EQL2025-04-25
04961333255719LARYNGOSTROBOSCOPEPENTAX OF AMERICA, INC.EQL2025-04-25
04961333255726LARYNGOSTROBOSCOPEPENTAX OF AMERICA, INC.EQL2025-04-25
04048551327074NAKarl Storz GmbH & Co. KGEQL2025-03-28
04953170458170OTV-S500 UPGRADE PACK STROBEOLYMPUS MEDICAL SYSTEMS CORP.EQL2025-03-17
04953170458231AIR MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.EQL2025-03-17
04953170458248MICROPHONE EXTENSION CABLEOLYMPUS MEDICAL SYSTEMS CORP.EQL2025-03-17
04953170458255HDMI CABLEOLYMPUS MEDICAL SYSTEMS CORP.EQL2025-03-17
04953170458354THROAT MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.EQL2025-03-17
04250365156034ATMOSATMOS MedizinTechnik GmbH & Co. KGEQL2024-11-27
04250365167832ATMOSATMOS MedizinTechnik GmbH & Co. KGEQL2024-11-27
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.EQL2024-11-14
08436041580256OptomicOPTOMIC ESPAÑA SAEQL2024-07-17
08436041580263OptomicOPTOMIC ESPAÑA SAEQL2024-07-17
00848657070218LaryngostroboscopeNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.EQL2023-10-12
04961333128174PENTAXHOYA CORPORATIONEQL2023-07-31
04042761069670OlympusOLYMPUS Winter & Ibe GmbHEQL2023-06-20
04580137730279MACHIDAMACHIDA ENDOSCOPE CO.,LTD.EQL2023-06-09
M6334949910JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-05-09
04961333253890PENTAX MedicalHOYA CORPORATIONEQL2023-03-13
M6337064050JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640510JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640520JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640710JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640720JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640730JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640740JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07