FDA.reportPublic FDA data

Guenter Bissinger Medizintechnik GmbH

Primary DI
04250418742290
Brand
Guenter Bissinger Medizintechnik GmbH
Company
Günter Bissinger Medizintechnik GmbH
Model
80516216
Catalog number
80516216
Device description
CLARIS Non-Stick Bip. Forceps 160 mm angled 0,6 mm insul. Flat-Plug
Published
2016-09-22
Public version status
Update
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
04250418742290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250418742290042504187422904250418742290

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
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250418753654Guenter Bissinger Medizintechnik GmbHWET-3UWET-3U2025-08-26
04250418749367Guenter Bissinger Medizintechnik GmbH82466340824663402025-07-30
04250418749374Guenter Bissinger Medizintechnik GmbH82466342824663422025-07-30
04250418751056Guenter Bissinger Medizintechnik GmbH82466341824663412025-07-30
04250418751063Guenter Bissinger Medizintechnik GmbH82466345824663452025-07-30
04250418751070Guenter Bissinger Medizintechnik GmbH82466346824663462025-07-30
04250418751087Guenter Bissinger Medizintechnik GmbH82466347824663472025-07-30
04250418751094Guenter Bissinger Medizintechnik GmbH82466312824663122025-07-30
04250418751100Guenter Bissinger Medizintechnik GmbH82466316824663162025-07-30
04250418751117Guenter Bissinger Medizintechnik GmbH82466318824663182025-07-30
04250418751124Guenter Bissinger Medizintechnik GmbH82466360824663602025-07-30
04250418751131Guenter Bissinger Medizintechnik GmbH82466361824663612025-07-30
04250418751148Guenter Bissinger Medizintechnik GmbH82466364824663642025-07-30
04250418751155Guenter Bissinger Medizintechnik GmbH82466365824663652025-07-30
04250418751162Guenter Bissinger Medizintechnik GmbH82466363824663632025-07-30
04250418751179Guenter Bissinger Medizintechnik GmbH82466367824663672025-07-30
04250418751186Guenter Bissinger Medizintechnik GmbH82466362824663622025-07-30
04250418751193Guenter Bissinger Medizintechnik GmbH82466366824663662025-07-30
04250418751209Guenter Bissinger Medizintechnik GmbH82466368824663682025-07-30
04250418753357CLARIS REVERSE Non-Stick Bipolar Forceps80580204805802042025-04-03

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