FDA.reportPublic FDA data

NA

Primary DI
04055207034101
Brand
NA
Company
Richard Wolf GmbH
Model
844204007
Catalog number
84420.4007
Device description
HF COAG. SUCTION TUBE OD 5.2MM WL 230MM with monopolar HF connection, 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
EWYMediastinoscope, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWYMediastinoscope, SurgicalEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207034101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207034101040552070341014055207034101

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length230Millimeter
Outer Diameter5.2Millimeter

Sterilization Methods#

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

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
04055207056585HIGHFLOW223560122356012017-07-21
04055207056592HIGHFLOW223561122356112017-07-21
04055207026526ERAGON BIPOLAR83930031839300312016-09-27
04055207026533ERAGON BIPOLAR83930032839300322016-09-27
04055207026540ERAGON BIPOLAR83930033839300332016-09-27
04055207026557ERAGON BIPOLAR83930034839300342016-09-27
04055207026564ERAGON BIPOLAR83930035839300352016-09-23
04055207026588ERAGON BIPOLAR83930041839300412016-09-27
04055207026724ERAGON BIPOLAR83930921839309212016-09-27
04055207033876ERAGON BIPOLAR8393001028393001022016-09-27
04055207055540ERAGON BIPOLAR83930037839300372016-09-27
04055207066805NA880888.082026-06-02
04055207007709NA180118.012026-05-29
04055207007723RIWO880388.032026-05-29
04055207007747NA890089.002026-05-29
04055207007792NA890589.052026-05-29
04055207007815NA890989.092026-05-29
04055207007839NA892089.202026-05-29
04055207008409NA8917189.1712026-05-29
04055207038505RIWO880088.002026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551425718NAKarl Storz GmbH & Co. KGEWY2025-03-27
24026704715293PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715309PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715316PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715323PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
24026704715330PILLINGTELEFLEX INCORPORATEDEWY2020-09-09
00863189000311Aegis Illuminated Mediastinal Access Port AEGIS SURGICAL LIMITEDEWY2017-03-14
00863189000304Aegis Illuminated Mediastinal Access PortAEGIS SURGICAL LIMITEDEWY2017-03-14
10863189000318Aegis Illuminated Mediastinal Access Port AEGIS SURGICAL LIMITEDEWY2017-03-14
00814334021644NARichard Wolf GmbHEWY2016-09-30
04055207001097NARichard Wolf GmbHEWY2016-09-26
04055207009284NARichard Wolf GmbHEWY2016-09-26
04055207014806NARichard Wolf GmbHEWY2016-09-26
04055207020623NARichard Wolf GmbHEWY2016-09-26
04048551049587n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551049594n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551049570n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551225387n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551225424n.a.Karl Storz GmbH & Co. KGEWY2016-09-23
04048551242889DCIKarl Storz GmbH & Co. KGEWY2016-09-23
04048551322062DCIKarl Storz GmbH & Co. KGEWY2016-09-23
04055207000014NARichard Wolf GmbHEWY2016-09-23
04055207009260NARichard Wolf GmbHEWY2016-09-23
04055207020616NARichard Wolf GmbHEWY2016-09-23
04055207020630NARichard Wolf GmbHEWY2016-09-23
04055207020647NARichard Wolf GmbHEWY2016-09-23
04055207034071NARichard Wolf GmbHEWY2016-09-23
04055207034088NARichard Wolf GmbHEWY2016-09-23
04055207034095NARichard Wolf GmbHEWY2016-09-23
04055207056400NARichard Wolf GmbHEWY2016-09-23