FDA.reportPublic FDA data

Guenter Bissinger Medizintechnik GmbH

Primary DI
04250418752497
Brand
Guenter Bissinger Medizintechnik GmbH
Company
Günter Bissinger Medizintechnik GmbH
Model
82460008
Catalog number
82460008
Device description
ORBITARIS rotatable handle, blue lockable, 2-pin-plug f. bipolar coag.
Published
2023-02-23
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
KNSUnit, electrosurgical, endoscopic (with or without accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250418752497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250418752497042504187524974250418752497

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
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

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