FDA.report

Olympus

Primary DI
36939029816734
Brand
Olympus
Company
Modern Medical Equipment MFG. Ltd.
Model
WA98531E
Device description
Open-surgery electrosurgical electrode, monopolar, single-use . Electrode, Blade, 4", Non-Coated.
Published
2018-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16939029816730PackageGS110In Commercial Distribution
26939029816737PackageGS110In Commercial Distribution
36939029816734PackageGS110In Commercial Distribution
06939029816733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1693902981673016939029816730
2693902981673726939029816737
3693902981673436939029816734
06939029816733069390298167336939029816733

GMDN Terms

TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods

Method

Regulatory Flags

DUNS number
527812392
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06939029818195OlympusEF4402021-05-07
06939029818201OlympusET8652021-05-07
06939029818218OlympusEF4412021-05-07
06939029818225OlympusET8652021-05-07
06939029818232OlympusEF4422021-05-07
06939029818249OlympusET8652021-05-08
06939029818256OlympusEF4422021-05-08
16939029818260OlympusET8652021-05-08
16939029818277OlympusET4562021-05-08
16939029818284OlympusET8652021-05-08
16939029818291OlympusEF4562021-05-08
06939029818300OlympusPD6502021-05-08
16939029818314OlympusPD7352021-05-08
06939029818324OlympusPD7352021-05-08
16939029818338OlympusPD6502021-05-08
06939029818348OlympusPD6502021-05-08
16939029818352OlympusPD7352021-05-08
26939029815167MEDLINE89055NS2017-12-16
26939029815174MEDLINE89056NS2017-12-16
26939029815181SEEMANNST-99-1002017-12-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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ESUM3644100SutterSutter Medizintechnik GmbHGEI2026-05-22
00845854035590CONCEPTConmed CorporationGEI2026-03-24
00190776417932MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776417956MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418076MillenniumAvalign Technologies, Inc.GEI2026-03-23
00190776418281MillenniumAvalign Technologies, Inc.GEI2026-03-23
00653405013924CONMEDConmed CorporationGEI2026-03-23
00198506089732ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
00198506089749ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
08800020101525POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108166DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108173DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108180DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108197DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108203DENSITYJeisys Medical Inc.GEI2026-03-16
08800020108289DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108272DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108296DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108302DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108319DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108326DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108395POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108401POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108425POTENZAJeisys Medical Inc.GEI2026-03-16
00198506089565ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-13
10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
10884450587802STAR™Merit Medical Systems, Inc.GEI2026-03-11
08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09