FDA.report

Spatula-electrode,adaptable,5/330mm

Primary DI
EMAH16004330
Brand
Spatula-electrode,adaptable,5/330mm
Company
mahe medical gmbh
Model
16.004.33
Catalog number
16.004.33
Device description
Spatula-electrode,adaptable,5/330mm
Published
2017-12-04
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
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EMAH16004330PrimaryHIBCC0

GMDN Terms

TermDefinition
Endoscopic electrosurgical electrode, monopolar, reusableAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. This is a reusable device.

Device Sizes

TypeValueUnit
Length330Millimeter

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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