FDA.reportPublic FDA data

PENTAX

Primary DI
04961333128174
Brand
PENTAX
Company
HOYA CORPORATION
Model
VE-B11
Device description
Carrying Case For VNL-ST VE-B11
Published
2023-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04961333128174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333128174049613331281744961333128174

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
691519705
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333227747PENTAXBS-LC12017-04-07
04961333228362PENTAXEG-3670URK2017-04-07
04961333228409PENTAXEG-3870UTK2017-04-07
04961333233793PENTAXEG-3270UK2018-08-10
04961333254316PENTAXEC-2990Li2024-07-26
04961333254323PENTAXEC34-i10L2024-07-26
04961333254330PENTAXEC-3890TLK2024-07-26
04961333254347PENTAXEC38-i10L2024-07-26
04961333254354PENTAXEC-3890Li2024-07-26
04961333254385PENTAXEG-2490K2024-07-26
04961333254392PENTAXEG27-i102024-07-26
04961333254408PENTAXEG-2990i2024-07-26
04961333254422PENTAXEG29-i102024-07-26
04961333254439PENTAXEG-3890TK2024-07-26
04961333255238VIVIDEOCP-10002025-12-19
04961333255306VIVIDEOVNL9-CP2025-12-19
04961333255191VIVIDEOCP-10002025-12-19
04961333255245VIVIDEOVNL9-CP2025-12-19
04961333254620PENTAX MedicalOE-B172024-12-13
04961333077731PENTAXOF-B1612023-07-31

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
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
M63370640720JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640730JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07
M63370640740JEDMEDJEDMED INSTRUMENT COMPANYEQL2023-02-07