FDA.reportPublic FDA data

Olympus

Primary DI
14042761075531
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
WA22655C
Catalog number
WA22655C
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FASElectrode, Electrosurgical, Active, Urological
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14042761075531PrimaryGS10
04042761075534Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404276107553114042761075531
04042761075534040427610755344042761075534

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-401-1086xx@xx.xx

Regulatory Flags#

DUNS number
316957240
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042761082297OlympusWA03300AWA03300A2016-09-22
04042761082303OlympusWA03310AWA03310A2016-09-22
14042761083369OlympusWT645010WT6450102023-06-20
04042761083324OlympusWT806450WT8064502023-01-27
04042761081757OlympusWA97013AWA97013A2023-06-20
04042761083102OlympusWT2187002023-06-20
04042761083119OlympusWT2187052023-06-20
04042761083126OlympusWT2187112023-06-20
04042761083133OlympusWT2187202023-06-20
04042761083140OlympusWT6304002023-06-20
04042761083164OlympusWT6400212023-06-20
04042761083171OlympusWT645001WT6450012023-06-20
04042761083188OlympusWT645006WT6450062023-06-20
04042761083218OlympusWT645013WT6450132023-06-20
04042761083225OlympusWT645016WT6450162023-06-20
04042761083232OlympusWT645017WT6450172023-06-20
04042761083256OlympusWT645020WT6450202023-06-20
04042761083263OlympusWT645025WT6450252023-06-20
04042761083270OlympusWT645030WT6450302023-06-20
04042761083287OlympusWT645031WT6450312023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548167NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548198NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548242NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548273NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327556421NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327556452NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327556476NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327556483NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327556513NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327556520NeptuneSTRYKER CORPORATIONGEI2024-12-10
00821925038875OlympusGyrus ACMI, LLCGEI2024-11-26
00821925043145DIEGO ELITEGyrus ACMI, LLCGEI2024-07-24
00821925043169DIEGO ELITEGyrus ACMI, LLCGEI2024-07-24
07613327466225StrykerSTRYKER CORPORATIONGEI2021-05-07
07613327467642StrykerSTRYKER CORPORATIONGEI2021-05-07
07613327539363StrykerSTRYKER CORPORATIONGEI2021-05-07
07613327539370StrykerSTRYKER CORPORATIONGEI2021-05-07
07613327539394StrykerSTRYKER CORPORATIONGEI2021-05-07
07613327466331StrykerSTRYKER CORPORATIONGEI2019-11-18
07613327465655StrykerSTRYKER CORPORATIONGEI2019-10-16
07613327465662StrykerSTRYKER CORPORATIONGEI2019-10-16
07613327465679StrykerSTRYKER CORPORATIONGEI2019-10-16
07613327465686StrykerSTRYKER CORPORATIONGEI2019-10-16
07613327465693StrykerSTRYKER CORPORATIONGEI2019-10-16
07613327466348StrykerSTRYKER CORPORATIONGEI2019-10-15