FDA.reportPublic FDA data

n.a.

Primary DI
04048551242506
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
40160021
Device description
LED Stroboscopy Light Source
Published
2019-02-23
Public version status
Update
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
04048551242506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551242506040485512425064048551242506

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, battery-poweredA battery-powered device 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., laparoscopes, gastroscopes). It is typically designed as a portable endoscope attachment whereby the bright light is channelled to the endoscope to illuminate the site of observation/intervention while minimizing tissue heating. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315731430
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

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
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