FDA.reportPublic FDA data

System Cable

Primary DI
04953170144929
Brand
System Cable
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-202
Published
2021-12-16
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
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
04953170144929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170144929049531701449294953170144929

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

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
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
04055207057537NARichard Wolf GmbHODA2017-07-21