FDA.report

mahe medical GmbH

Primary DI
04050659357242
Brand
mahe medical GmbH
Company
mahe medical gmbh
Model
26.132.33
Device description
Alligator grasp.fcps.,10/330mm _x000D_ _x000D_
Published
2019-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050659357242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050659357242040506593572424050659357242

GMDN Terms

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

Regulatory Flags

DUNS number
342243334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04050659161702mahe medical GmbH001-0001-006S2019-11-05
04050659161719mahe medical GmbH001-0001-006ST2019-11-05
04050659161726mahe medical GmbH001-0001-006XS2019-11-05
04050659161740mahe medical GmbH001-0001-007S2019-11-05
04050659161757mahe medical GmbH001-0001-007ST2019-11-05
04050659161764mahe medical GmbH001-0001-007XS2019-11-05
04050659161801mahe medical GmbH001-0001-008XS2019-11-05
04050659161825mahe medical GmbH001-0001-009S2019-11-05
04050659161849mahe medical GmbH001-0001-009XS2019-11-05
04050659161863mahe medical GmbH001-0001-010S2019-11-05
04050659161887mahe medical GmbH001-0001-010XS2019-11-05
04050659161948mahe medical GmbH001-0001-012S2019-11-05
04050659161962mahe medical GmbH001-0001-012XS2019-11-05
04050659162013mahe medical GmbH001-0001-014S2019-11-05
04050659162037mahe medical GmbH001-0001-014XS2019-11-05
04050659162051mahe medical GmbH001-0001-016S2019-11-05
04050659162068mahe medical GmbH001-0001-016ST2019-11-05
04050659162075mahe medical GmbH001-0001-016XS2019-11-05
04050659162112mahe medical GmbH001-0001-018XS2019-11-05
04050659162150mahe medical GmbH001-0001-020XS2019-11-05

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