FDA.reportPublic FDA data

NA

Primary DI
04055207001066
Brand
NA
Company
Richard Wolf GmbH
Model
8765612
Catalog number
8765.612
Device description
ELECTRODE BIPO Ø 1.9MM WL 400MM reusable
Published
2016-09-28
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWGENDOSCOPE, NEUROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWGEndoscope, NeurologicalNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207001066PrimaryGS10
04055207059630Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207001066040552070010664055207001066
04055207059630040552070596304055207059630

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, reusableAn 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 (including 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). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length400Millimeter
Outer Diameter1.9Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
315304071
Device count
5
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
true
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048438000175NAKarl Storz GmbH & Co. KGGWG2025-03-27
00810004820401Clarus Digital ChannelScope Endoscope, 21.6cm, 3.5mm ODCLARUS MEDICAL, LLCGWG2024-12-23
00810004820418Clarus Digital ChannelScope Endoscope, 21.6cmCLARUS MEDICAL, LLCGWG2024-12-23
04048551436271n.a.Karl Storz GmbH & Co. KGGWG2024-11-28
04055207069981RIWORichard Wolf GmbHGWG2024-08-19
00810004820012Clarus Digital ChannelScope Endoscope, 13.0cmCLARUS MEDICAL, LLCGWG2024-02-19
00810004820357Clarus Digital NeuroPEN Endoscope, 15.5cmCLARUS MEDICAL, LLCGWG2024-02-19
00810004820395Clarus Digital ChannelScope Endoscope, 11.0cmCLARUS MEDICAL, LLCGWG2024-02-19
00810004820494Clarus Digital NeuroPEN Endoscope, 19.0cmCLARUS MEDICAL, LLCGWG2024-02-19
00810004821026Clarus Digital ClarusScope EndoscopeCLARUS MEDICAL, LLCGWG2024-02-19
00810004821019Clarus Digital Control ModuleCLARUS MEDICAL, LLCGWG2024-02-19
00850002332278Aurora® Surgiscope®Integra Lifesciences CorporationGWG2023-11-09
10813040013704VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR)VISIONSENSE LTD.GWG2020-06-11
10813040013728VS3 Iridium - Laser Light Source, 785nm (LLS)VISIONSENSE LTD.GWG2020-06-11
10813040013032Power Cord for VS3 Cart - ItalyVISIONSENSE LTD.GWG2019-11-25
10813040013070Power Cord for VS3 Cart - USVISIONSENSE LTD.GWG2019-11-25
04048551105221n.a.Karl Storz GmbH & Co. KGGWG2017-10-20
04048551396001TIPCAMKarl Storz GmbH & Co. KGGWG2017-05-19
04048551396018TIPCAMKarl Storz GmbH & Co. KGGWG2017-05-19
04048551007624n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007631n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007648n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007655n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007778n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007785n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007792n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007815CLICKLINEKarl Storz GmbH & Co. KGGWG2016-09-23
04048551007907n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007914n.a.Karl Storz GmbH & Co. KGGWG2016-09-23
04048551007921n.a.Karl Storz GmbH & Co. KGGWG2016-09-23