FDA.reportPublic FDA data

Guenter Bissinger Medizintechnik GmbH

Primary DI
04250418753722
Brand
Guenter Bissinger Medizintechnik GmbH
Company
Günter Bissinger Medizintechnik GmbH
Model
82460349
Catalog number
82460349
Device description
MITHRAS Electrode Ø 3 mm 15 cm, Forceps Tip Non-Stick
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04250418753722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250418753722042504187537224250418753722

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

Contacts#

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

Regulatory Flags#

DUNS number
326515533
Device count
1
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
04250418748346Guenter Bissinger Medizintechnik GmbH82460326824603262026-07-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16