FDA.reportPublic FDA data

Uretero-Renoscope,425mm,rigid,distal end 6/7.5Ch., work.channel 4Ch.

Primary DI
EMAH35003060
Brand
Uretero-Renoscope,425mm,rigid,distal end 6/7.5Ch., work.channel 4Ch.
Company
mahe medical gmbh
Model
35.003.06
Catalog number
35.003.06
Device description
Uretero-Renoscope,425mm,rigid,distal end6/7.5Ch., work.channel 4Ch. direct.of view 8° to working channel
Published
2018-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMAH35003060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ResectoscopeAn endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length425Millimeter

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EMAHKM714590Steinmann pin w. double end trocarpoint 3.2mm/229mm, 6 pcs./unitKM71-459KM71-4592016-06-13
EMAHKM715100Steinmann pin w. trocar/round end 2.0mm/229mm, 6 pcs./unitKM71-510KM71-5102016-04-28
EMAHKM715130Steinmann pin w. trocar/round end 2.4mm/229mm, 6 pcs./unitKM71-513KM71-5132016-04-28
EMAHKM718800Steinmann pin 3 Shank End, Diamond Point 2.0mm/229mm, Sutur PasserKM71-880KM71-8802016-06-10
04050659210974mahe medical GmbH004-800092019-11-05
04050659484832mahe medical GmbHKM71-4592019-11-05
04050659484948mahe medical GmbHKM71-5102019-11-05
04050659484955mahe medical GmbHKM71-5132019-11-05
04050659485228mahe medical GmbHKM71-6752019-11-05
04050659485600mahe medical GmbHKM71-8802019-11-05
EMAHCHM01100Set screw w.plate f.polyaxial screwsCHM01-10CHM01-102016-07-05
EMAHCHM01110Set screw f.polyaxial screwsCHM01-11CHM01-112016-07-05
EMAHPSR1175450Polyaxial screw reduct., w/o cannulation 7.5mm/45mmPSR11-7545PSR11-75452016-08-04
EMAHPSR1175500Polyaxial screw reduct., w/o cannulation 7.5mm/50mmPSR11-7550PSR11-75502016-08-04
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
EMAHPSS0845350Polyaxial screw, w/o cannulation, 4.5mm/35mmPSS08-4535PSS08-45352016-07-06
EMAHPSS0845400Polyaxial screw, w/o cannulation, 4.5mm/40mmPSS08-4540PSS08-45402016-07-06

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