FDA.reportPublic FDA data

mahe medical GmbH

Primary DI
04050659372276
Brand
mahe medical GmbH
Company
mahe medical gmbh
Model
36.014.24
Device description
Roller barrel resectoscopy electrode, _x000D_24Ch.,roller diam.3.0mm _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
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
04050659372276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050659372276040506593722764050659372276

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

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00630414606460epoc Host2Epocal IncJFL2020-07-15
00630414606095epoc NXS HostEpocal IncJFL2020-06-18
10054749005519i-STATABBOTT POINT OF CARE INC.JFL2020-05-01
04050659367975mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368057mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368217mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368293mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659368828mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371248mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371682mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371743mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659371750mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659372214mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659373631mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659373655mahe medical GmbHmahe medical gmbhJFL2019-11-05
04050659373693mahe medical GmbHmahe medical gmbhJFL2019-11-05
EMAH3601319SL0HF-roller ball resectoscopy electrode, roller diam.3.0mm,24Chmahe medical gmbhJFL2018-12-10
EMAH3500915QL0Lithotripsy Telescope bridge w.7Ch. working channelmahe medical gmbhJFL2018-02-05
00630414596518Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl-Siemens Healthcare Diagnostics Inc.JFL2017-12-22
00385480183420NOVANOVA BIOMEDICAL CORPORATIONJFL2017-04-24
EMAH36014240Roller barrel resectoscopy electrode, 24Ch.,roller diam.3.0mmmahe medical gmbhJFL2017-02-09
00842768014017Dimension® QuikLYTE® Integrated Multisensor Sample DiluentSiemens Healthcare Diagnostics Inc.JFL2016-09-24
00842768014024Dimension® QuikLYTE® Integrated Multisensor Diluent CheckSiemens Healthcare Diagnostics Inc.JFL2016-09-24
00842768014291Dimension® QuikLYTE® Multisensor Na+/K+/Cl-Siemens Healthcare Diagnostics Inc.JFL2016-09-24
00842768014307Dimension® QuikLYTE® Multisensor Flush SolutionSiemens Healthcare Diagnostics Inc.JFL2016-09-24
00385480001250NOVANOVA BIOMEDICAL CORPORATIONJFL2016-09-20
00385480215886NOVANOVA BIOMEDICAL CORPORATIONJFL2016-09-20
00385480539852NovaNOVA BIOMEDICAL CORPORATIONJFL2016-09-20