FDA.report

NA

Primary DI
04055207008133
Brand
NA
Company
Richard Wolf GmbH
Model
82403
Catalog number
824.03
Device description
NEEDLE ELECTRODE MONO 2.4FR WL 260MM for cystoscopy, electrode shape: needle, PACK=1 PC, reusable
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JOSElectrode, electrosurgical

Product Code Classifications

CodeDeviceSpecialtyClass
JOSElectrode, ElectrosurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207008133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207008133040552070081334055207008133

GMDN Terms

TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) 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 or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Device Sizes

TypeValueUnit
Length260Millimeter
Outer Diameter0.8Millimeter

Sterilization Methods

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

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00821925008083BovieGyrus Acmi, Inc.JOS2024-07-25
00821925008458BovieGyrus Acmi, Inc.JOS2024-07-25
00845854030632CONMEDConmed CorporationJOS2023-12-05
08809295147177V-TipRF Medical Co.,Ltd.JOS2023-10-23
10841019116903KirwanKIRWAN SURGICAL PRODUCTS LLCJOS2022-01-28
10841019117092KirwanKIRWAN SURGICAL PRODUCTS LLCJOS2022-01-28
10841019117115KirwanKIRWAN SURGICAL PRODUCTS LLCJOS2022-01-28
10841019117122KirwanKIRWAN SURGICAL PRODUCTS LLCJOS2022-01-28
10841019119102KirwanKIRWAN SURGICAL PRODUCTS LLCJOS2021-02-23
10841019119119KirwanKIRWAN SURGICAL PRODUCTS LLCJOS2021-02-23
10841019119126KirwanKIRWAN SURGICAL PRODUCTS LLCJOS2021-02-23
10841019119140KirwanKIRWAN SURGICAL PRODUCTS LLCJOS2021-02-23
10841019119225KirwanKIRWAN SURGICAL PRODUCTS LLCJOS2021-02-23
00841645103516ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103523ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103530ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103721ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103738ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103745ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103752ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103769ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103776ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103783ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103790ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103806ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103813ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103820ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103837ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103844ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25
00841645103851ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONJOS2016-09-25