FDA.reportPublic FDA data

mahe medical GmbH

Primary DI
04050659371484
Brand
mahe medical GmbH
Company
mahe medical gmbh
Model
36.005.02
Device description
Resectoscopy working unit,active, _x000D_closed handle,24/26/28.5Ch _x000D_
Published
2019-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FDCResectoscope, working element

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDCResectoscope, Working ElementGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050659371484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050659371484040506593714844050659371484

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342243334
Device count
1
Lot or batch
true
Serial number
true
Donation ID number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207063200ERAGONRichard Wolf GmbHFDC2025-10-20
03665415002840Active working element (SIDE load; round ; Fr26 ; WOLF compatible)LAMIDEY NOURY MEDICALFDC2025-10-08
03665415002857Passive working element (SIDE load; round ; Fr26 ; WOLF compatible)LAMIDEY NOURY MEDICALFDC2025-10-08
03665415002888Passive working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compatLAMIDEY NOURY MEDICALFDC2025-10-08
03665415002895Active working element UNIV extra length (SIDE LOAD; round; Fr 26; STORZ compatiLAMIDEY NOURY MEDICALFDC2025-10-08
00848657077491AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2025-08-25
03665415002772Bipolar cutting loop / SLIM (round; Fr22)LAMIDEY NOURY MEDICALFDC2025-04-24
03665415002796Active working element (SIDE load; round ; Fr22 ; STORZ compatible)LAMIDEY NOURY MEDICALFDC2025-04-24
03665415002802Passive working element (SIDE load; round ; Fr22 ; STORZ compatible)LAMIDEY NOURY MEDICALFDC2025-04-24
04048438000175NAKarl Storz GmbH & Co. KGFDC2025-03-27
04048438005408n.a.Karl Storz GmbH & Co. KGFDC2024-10-04
04055207056691NARichard Wolf GmbHFDC2024-03-29
04055207056707NARichard Wolf GmbHFDC2024-03-29
04055207057247NARichard Wolf GmbHFDC2024-03-29
04055207057254NARichard Wolf GmbHFDC2024-03-29
04055207057261NARichard Wolf GmbHFDC2024-03-29
04055207057278NARichard Wolf GmbHFDC2024-03-29
04055207057285NARichard Wolf GmbHFDC2024-03-29
04055207057292NARichard Wolf GmbHFDC2024-03-29
04055207057308NARichard Wolf GmbHFDC2024-03-29
04055207057315NARichard Wolf GmbHFDC2024-03-29
04055207057339SHARKRichard Wolf GmbHFDC2024-03-29
00848657018951WA22507D BIPOLAR LOOP 24FR LARGE - 30 DEGREENATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
00848657018982WA22306D BIPOLAR LOOP 24FR - 30 DEGREENATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
00848657019019AED-WA22355C BIPOLAR NEEDLE ELECTRODE 24FR - ANGLE TIPNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
00848657019033AED-WA22557C BUTTON ELECTRODE - BIPOLAR 24FR - 90 DEGREE - PLASMANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2023-04-24
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)LAMIDEY NOURY MEDICALFDC2023-04-21