FDA.reportPublic FDA data

Guenter Bissinger Medizintechnik GmbH

Primary DI
04250418748858
Brand
Guenter Bissinger Medizintechnik GmbH
Company
Günter Bissinger Medizintechnik GmbH
Model
WFE-3U
Catalog number
WFE-3U
Published
2020-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250418748858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250418748858042504187488584250418748858

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, bipolar, reusableA rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497641914330info@bissinger.com

Regulatory Flags#

DUNS number
326515533
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250418753395Guenter Bissinger Medizintechnik GmbH84919320849193202025-03-27
04250418753401Guenter Bissinger Medizintechnik GmbH84919321849193212025-03-27
04250418753418Guenter Bissinger Medizintechnik GmbH84921320849213202025-03-27
04250418753425Guenter Bissinger Medizintechnik GmbH84921321849213212025-03-27
04250418753432Guenter Bissinger Medizintechnik GmbH84923320849233202025-03-27
04250418753449Guenter Bissinger Medizintechnik GmbH84923321849233212025-03-27
04250418753296Guenter Bissinger Medizintechnik GmbH84923301849233012025-01-02
04250418753302Guenter Bissinger Medizintechnik GmbH84923310849233102025-01-02
04250418753319Guenter Bissinger Medizintechnik GmbH84923311849233112025-01-02
04250418753326Guenter Bissinger Medizintechnik GmbH84923330849233302025-01-02
04250418753333Guenter Bissinger Medizintechnik GmbH84923340849233402025-01-02
04250418753258Guenter Bissinger Medizintechnik GmbH84921311849213112024-12-18
04250418753265Guenter Bissinger Medizintechnik GmbH84921330849213302024-12-18
04250418753272Guenter Bissinger Medizintechnik GmbH84921340849213402024-12-18
04250418753289Guenter Bissinger Medizintechnik GmbH84923300849233002024-12-18
04250418753166Guenter Bissinger Medizintechnik GmbH84919300849193002024-12-17
04250418753173Guenter Bissinger Medizintechnik GmbH84919301849193012024-12-17
04250418753180Guenter Bissinger Medizintechnik GmbH84919310849193102024-12-17
04250418753197Guenter Bissinger Medizintechnik GmbH84919311849193112024-12-17
04250418753203Guenter Bissinger Medizintechnik GmbH84919330849193302024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
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00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03