FDA.reportPublic FDA data

Roller barrel resectoscopy electrode, 24Ch.,roller diam.3.0mm

Primary DI
EMAH36014240
Brand
Roller barrel resectoscopy electrode, 24Ch.,roller diam.3.0mm
Company
mahe medical gmbh
Model
36.014.24
Catalog number
36.014.24
Device description
Roller barrel resectoscopy electrode, 24Ch.,roller diam.3.0mm
Published
2017-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JFLPH RATE MEASUREMENT, CARBON-DIOXIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFLPh Rate Measurement, Carbon-DioxideClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMAH36014240PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49(0)746592750info@mahe-med.de

Regulatory Flags#

DUNS number
342243334
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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EMAHCHM01100Set screw w.plate f.polyaxial screwsCHM01-10CHM01-102016-07-05
EMAHCHM01110Set screw f.polyaxial screwsCHM01-11CHM01-112016-07-05
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EMAHPSR1175550Polyaxial screw reduct., w/o cannulation 7.5mm/55mmPSR11-7555PSR11-75552016-08-04
EMAHPSR1175600Polyaxial screw reduct., w/o cannulation 7.5mm/60mmPSR11-7560PSR11-75602016-08-04
EMAHPSS0845250Polyaxial screw, w/o cannulation, 4.5mm/25mmPSS08-4525PSS08-45252016-07-05
EMAHPSS0845300Polyaxial screw, w/o cannulation, 4.5mm/30mmPSS08-4530PSS08-45302016-07-06
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EMAHPSS0845400Polyaxial screw, w/o cannulation, 4.5mm/40mmPSS08-4540PSS08-45402016-07-06

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