FDA.report

mahe medical GmbH

Primary DI
04050659367869
Brand
mahe medical GmbH
Company
mahe medical gmbh
Model
35.005.02
Device description
Telescope bridge w.2 working channels, _x000D_for 4.0mm optic _x000D_
Published
2019-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FDCResectoscope, working element

Product Code Classifications

CodeDeviceSpecialtyClass
FDCResectoscope, Working ElementGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04050659367869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04050659367869040506593678694050659367869

GMDN Terms

TermDefinition
Rigid endoscope working guideAn endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device.

Sterilization Methods

Method

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
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04050659161702mahe medical GmbH001-0001-006S2019-11-05
04050659161719mahe medical GmbH001-0001-006ST2019-11-05
04050659161726mahe medical GmbH001-0001-006XS2019-11-05
04050659161740mahe medical GmbH001-0001-007S2019-11-05
04050659161757mahe medical GmbH001-0001-007ST2019-11-05
04050659161764mahe medical GmbH001-0001-007XS2019-11-05
04050659161801mahe medical GmbH001-0001-008XS2019-11-05
04050659161825mahe medical GmbH001-0001-009S2019-11-05
04050659161849mahe medical GmbH001-0001-009XS2019-11-05
04050659161863mahe medical GmbH001-0001-010S2019-11-05
04050659161887mahe medical GmbH001-0001-010XS2019-11-05
04050659161948mahe medical GmbH001-0001-012S2019-11-05
04050659161962mahe medical GmbH001-0001-012XS2019-11-05
04050659162013mahe medical GmbH001-0001-014S2019-11-05
04050659162037mahe medical GmbH001-0001-014XS2019-11-05
04050659162051mahe medical GmbH001-0001-016S2019-11-05
04050659162068mahe medical GmbH001-0001-016ST2019-11-05
04050659162075mahe medical GmbH001-0001-016XS2019-11-05
04050659162112mahe medical GmbH001-0001-018XS2019-11-05
04050659162150mahe medical GmbH001-0001-020XS2019-11-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00848657077491AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FDC2025-08-25
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
04055207019603SHARKRichard Wolf GmbHFDC2023-03-07
04050659367838mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659371477mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659371484mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659371606mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659372108mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659372191mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659373532mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659373549mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659373556mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659376205mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659376212mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659376229mahe medical GmbHmahe medical gmbhFDC2019-11-05
04050659376236mahe medical GmbHmahe medical gmbhFDC2019-11-05