FDA.report

Olympus

Primary DI
36939029816765
Brand
Olympus
Company
Modern Medical Equipment MFG. Ltd.
Model
WA98550E
Device description
Open-surgery electrosurgical electrode, monopolar, single-use . Electrode, Blade, 6", 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
16939029816761PackageGS110In Commercial Distribution
26939029816768PackageGS110In Commercial Distribution
36939029816765PackageGS110In Commercial Distribution
06939029816764PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorEAN-13Conversion note
1693902981676114169390298167611Indicator 1 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
2693902981676814269390298167682Indicator 2 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
3693902981676514369390298167653Indicator 3 usually represents packaging or variable measure; UPC/EAN conversion is not shown.
06939029816764140693902981676406939029816764Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00.

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

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10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
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08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD8800290Surgical DirectSurgical Direct, Inc.GEI2026-03-09
B382SD881190Surgical DirectSurgical Direct, Inc.GEI2026-03-09