FDA.reportPublic FDA data

SHARK/S-LINE

Primary DI
04055207018033
Brand
SHARK/S-LINE
Company
Richard Wolf GmbH
Model
8623022
Catalog number
8623022
Device description
COAG ELECTRODE BIPO 22-26FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, continuous irrigation, 22/24/26, Fr, electrode shape: cylinder, wire Ø 1.2mm, fork color blue, stem color yellow, PACK=1 PC, for Shark and S-Line Resectoscopes, unsterile, reusable
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
JOSElectrode, electrosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2
JOSElectrode, ElectrosurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207018033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207018033040552070180334055207018033

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Ethylene Oxide;Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23
04055207013823NA80611638061.1632016-09-23
04055207013830NA80612538061.2532016-09-23
04055207013854NA80613538061.3532016-09-23
04055207013861NA80613568061.3562016-09-23
04055207013878NA80614538061.4532016-09-23
04055207013885NA80614568061.4562016-09-23
04055207013892NA80614578061.4572016-09-23
04055207013908NA80618538061.8532016-09-23
04055207013922NA80622518062.2512016-09-23
04055207013939NA80623518062.3512016-09-23
04055207013946NA80624518062.4512016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809295141007BIG-TIP™ RF Medical Co.,Ltd.JOS2025-09-05
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08904148101525ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101570ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101587ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101600ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08800142925092THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925108THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925115THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142925122THYBLATE-V2™RF Medical Co.,Ltd.JOS2025-02-05
08800142919206THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08800142919213THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08800142919220THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-24
08809295147382V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147399V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147405V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147412V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147429V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147436V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147443V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147450V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147467V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147474V-TipRF Medical Co.,Ltd.JOS2023-10-24
08809295147481V-TipRF Medical Co.,Ltd.JOS2023-10-24
08800142919190THYBLATE-V™RF Medical Co.,Ltd.JOS2023-10-23
08809295147108V-TipRF Medical Co.,Ltd.JOS2023-10-23
08809295147115V-TipRF Medical Co.,Ltd.JOS2023-10-23
08809295147122V-TipRF Medical Co.,Ltd.JOS2023-10-23
08809295147139V-TipRF Medical Co.,Ltd.JOS2023-10-23
08809295147146V-TipRF Medical Co.,Ltd.JOS2023-10-23