FDA.reportPublic FDA data

JEDMED

Primary DI
M63370X65280
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
70X6528
Catalog number
70X6528
Device description
CAMERA & CABLE W/22MM COUPLER
Published
2023-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
M63370X65280PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
LaryngostroboscopeA device that is intended to allow the observation of glottic action during phonation (speech) in the examination of voice disorders. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. It can contain a microphone that captures the acoustic signals from the glottic area and may or may not contact the patient.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092987189
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M63330170506L0JEDMED30-1705 06L30-1705 06L2020-09-01
M63330170506R0JEDMED30-1705 06R30-1705 06R2020-09-01
M63330170579H0JEDMED30-1705 79H30-1705 79H2020-09-01
M6333018340JEDMED30-183430-18342020-09-01
M6333018350JEDMED30-183530-18352020-09-01
M6333018360JEDMED30-183630-18362020-09-01
M6333103500JEDMED31-035031-03502020-09-01
M6333103510JEDMED31-035131-03512020-09-01
M6333104600JEDMED31-046031-04602020-09-01
M6333104750JEDMED31-047531-04752020-09-01
M63331047570JEDMED31-0475 731-0475 72020-09-01
M6333104760JEDMED31-047631-04762020-09-01
M63331047650JEDMED31-0476 531-0476 52020-09-01
M6333104770JEDMED31-047731-04772020-09-01
M6339982060JEDMED99-820699-82062023-02-03
M6339977070JEDMED99-770799-77072023-02-03
M6339977080JEDMED99-770899-77082023-02-03
M6339977090JEDMED99-770999-77092023-02-03
M6339977100JEDMED99-771099-77102023-02-03
M6339977110JEDMED99-771199-77112023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONEQL2026-08-25
04580826929861PENTAX MedicalPENTAX MEDICAL CORPORATIONEQL2026-08-25
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
04042761069663OlympusOLYMPUS Winter & Ibe GmbHEQL2023-06-20
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