FDA.reportPublic FDA data

XENON LUMP

Primary DI
04953170400476
Brand
XENON LUMP
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MD-631
Published
2021-12-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCTLight Source, Endoscope, Xenon Arc

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCTLight Source, Endoscope, Xenon ArcGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170400476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170400476049531704004764953170400476

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, line-poweredA mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10845854080634CONMEDConmed CorporationGCT2026-03-24
10845854041291CONMEDConmed CorporationGCT2026-03-24
00840183528607BR Surgical, LLCBR Surgical, LLCGCT2024-10-24
04048551057261n.a.Karl Storz GmbH & Co. KGGCT2024-10-16
00857556008468BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
00857556008475BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
00857556008543BR Surgical, LLCBR Surgical, LLCGCT2024-07-22
10845854041307CONMEDConmed CorporationGCT2023-12-04
10845854041314CONMEDConmed CorporationGCT2023-12-04
04961333083701PENTAXHOYA CORPORATIONGCT2023-07-31
04250369707317ILOILO electronic GmbHGCT2023-06-22
04250369707324ILOILO electronic GmbHGCT2023-06-22
04250369707348ILOILO electronic GmbHGCT2023-06-22
04250369707355ILOILO electronic GmbHGCT2023-06-22
04250369707362ILOILO electronic GmbHGCT2023-06-22
04250369707379ILOILO electronic GmbHGCT2023-06-22
04250369707690ILOILO electronic GmbHGCT2023-06-22
04250369707706ILOILO electronic GmbHGCT2023-06-22
04250369707713ILOILO electronic GmbHGCT2023-06-22
04250369707720ILOILO electronic GmbHGCT2023-06-22
04250369707737ILOILO electronic GmbHGCT2023-06-22
04250369707744ILOILO electronic GmbHGCT2023-06-22
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.GCT2021-12-17
04048551166116n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551325995n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346266n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346273n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551346303n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
04048551062838n.a.Karl Storz GmbH & Co. KGGCT2019-02-23
00857580006669Light SourceGULF FIBEROPTICS, INC.GCT2017-12-01