FDA.report

Olympus

Primary DI
36939029816741
Brand
Olympus
Company
Modern Medical Equipment MFG. Ltd.
Model
WA98540E
Device description
Open-surgery electrosurgical electrode, monopolar, single-use . Electrode, Blade, 4", Coated, Extended Insulation.
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
16939029816747PackageGS110In Commercial Distribution
26939029816744PackageGS110In Commercial Distribution
36939029816741PackageGS110In Commercial Distribution
06939029816740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1693902981674716939029816747
2693902981674426939029816744
3693902981674136939029816741
06939029816740069390298167406939029816740

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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