FDA.reportPublic FDA data

Olympus

Primary DI
14042761036815
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
A22251C
Catalog number
A22251C
Published
2016-09-21
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

Product Codes#

Code, Name table
CodeName
GCPEndoscope, Ac-Powered And Accessories
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCPEndoscope, Ac-Powered And AccessoriesGastroenterology, Urology2
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14042761036815PrimaryGS10
04042761036818Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404276103681514042761036815
04042761036818040427610368184042761036818

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact 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 ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316957240
Device count
12
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809909421716CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421693CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-24
08051887044719THD N-Ano anoscopesTHD SPAGCP2025-03-14
08051887044733THD N-Ano anoscopeTHD SPAGCP2025-03-14
08051887044757THD N-Ano AnoscopeTHD SPAGCP2025-03-14
08051887044771THD N-ano anoscopeTHD SPAGCP2025-03-14
00724995226732Padlock ClipUS EndoscopyKNS2024-10-31
08809922260637ELRA ElectrodeSTARMED CO.,LTDKNS2024-08-28
20653405051555APOLLO3Conmed CorporationKNS2024-07-22
20653405051562APOLLO3Conmed CorporationKNS2024-07-22
00191506008086Axios™BOSTON SCIENTIFIC CORPORATIONKNS2021-05-27
00191506008093Axios™BOSTON SCIENTIFIC CORPORATIONKNS2021-05-27
00816207021577ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021584ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021591ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021607ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021614ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021621ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021638ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021645ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00816207021652ezSnare Polypectomy SnareENDO-THERAPEUTICS, INC.KNS2021-01-29
00724995180683NAUS EndoscopyKNS2020-04-02
00724995180690NAUS EndoscopyKNS2020-04-02
00724995180706NAUS EndoscopyKNS2020-04-02
00724995180515TorrentUS EndoscopyKNS2020-04-01
00724995180522TorrentUS EndoscopyKNS2020-04-01
08714729979333Axios™BOSTON SCIENTIFIC CORPORATIONKNS2019-11-25
08809306762344ELRA ElectrodeSTARMED CO.,LTDKNS2019-04-19
08809306762351ELRA ElectrodeSTARMED CO.,LTDKNS2019-04-19