FDA.reportPublic FDA data

Remote Cable

Primary DI
04953170355837
Brand
Remote Cable
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1021
Device description
MAJ-1021 EU-M60/EndoAlpha remote cable
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODAendoscopic central control unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODAEndoscopic Central Control UnitGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981993000OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHAThe Olympus Optical Co.1998-08-21ODA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170355837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170355837049531703558374953170355837

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
711789789
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556813683INTELLIO TabletSmith & Nephew, Inc.ODA2023-05-17
00885556866108INTELLIO TabletSmith & Nephew, Inc.ODA2023-05-17
04953170435201SYSTEMS INTEGRATION ENDOALPHAOLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-21
04953170328985UPGRADE KIT FOR UCES-3(Version4)OLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-17
04953170144929System CableOLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-16
04953170148040Universal display for ENDOALPHAOLYMPUS MEDICAL SYSTEMS CORP.ODA2021-12-16
04953170406461UCES-4 Upgrade Pack 2OLYMPUS MEDICAL SYSTEMS CORP.ODA2020-08-06
00885556778777LENS CONNECTED TOWER APPLICATIONSmith & Nephew, Inc.ODA2020-03-22
04048551416778n.a.Karl Storz GmbH & Co. KGODA2020-03-02
04953170391767MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391804EXTENSION UNIT FOR UCES-4OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391842INTERFACE FOR ESU (VIO SERIES)OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391873INTERFACE FOR ESU (FORCE SERIES)OLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391903UNIVERSAL INTERFACEOLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04953170391965INTERFACE FOR OLYMPUS LINK DEVICEOLYMPUS MEDICAL SYSTEMS CORP.ODA2018-09-16
04048551242575n.a.Karl Storz GmbH & Co. KGODA2018-08-17
04048551357286n.a.Karl Storz GmbH & Co. KGODA2017-10-20
04048551392270n.a.Karl Storz GmbH & Co. KGODA2017-10-20
04953170136597REMOTE CABLEOLYMPUS MEDICAL SYSTEMS CORP.ODA2017-10-12
04055207013397NARichard Wolf GmbHODA2017-07-21
04055207013403NARichard Wolf GmbHODA2017-07-21
04055207013410NARichard Wolf GmbHODA2017-07-21
04055207013427NARichard Wolf GmbHODA2017-07-21
04055207013434NARichard Wolf GmbHODA2017-07-21
04055207013441NARichard Wolf GmbHODA2017-07-21
04055207041031NARichard Wolf GmbHODA2017-07-21
04055207057476NARichard Wolf GmbHODA2017-07-21
04055207057506NARichard Wolf GmbHODA2017-07-21
04055207057513NARichard Wolf GmbHODA2017-07-21
04055207057520NARichard Wolf GmbHODA2017-07-21