FDA.report

HF-knife 24CH Saline- resectoscopy electrotrode

Primary DI
EMAH3601224SL0
Brand
HF-knife 24CH Saline- resectoscopy electrotrode
Company
mahe medical gmbh
Model
36.012.24SL
Catalog number
36.012.24SL
Device description
HF-knife 24CH Saline- resectoscopy electrotrode
Published
2017-09-28
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

Related Records

Contact Domains

Product Codes

CodeName
FDCRESECTOSCOPE, WORKING ELEMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FDCResectoscope, Working ElementGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EMAH3601224SL0PrimaryHIBCC0

GMDN Terms

TermDefinition
Electrosurgical return electrode, reusableA dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may be designed with permanently attached cables. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+49(0)746592750info@mahe-med.de

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
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
false

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