FDA.reportPublic FDA data

Autoclavable HD-Zoom Coupler

Primary DI
04056702005665
Brand
Autoclavable HD-Zoom Coupler
Company
W.O.M. World of Medicine GmbH
Model
EZ241
Published
2020-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FEIInstrument, Special Lens, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEIInstrument, Special Lens, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056702005665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056702005665040567020056654056702005665

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316305242
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056702012007Tube set for irrigation, single-useTS-P106-A2842302026-03-10
04056702012021Tube set for suction, 2-lines, single-useTS-P107-A2842312026-03-10
04056702012045Day use tube set for irrigation, pump part, 10 applicationsTS-P508-A2842322026-03-10
04056702012069Patient tube for irrigation, single-useTS-P508-A2842332026-03-10
04056702012083Tube set for vacuum, incl. filter, 30-day useTS-P501-C2842352026-03-10
04056702012106Tube set for suction, single-useTS-P102-H2842362026-03-10
04056702012120Tube set inflow 4-Spike adaptorTS-P502-A2842342026-03-10
04056702011970PUREVUE™ FMSPA1242842262026-03-10
04056702011987Autoclavable remote controlB022842272026-03-10
04056702011994Double pedal foot switchPZ3002842282026-03-10
04056702012014Tube set for irrigation, single-useTS-P106-A2026-03-10
04056702012038Tube set for suction, 2-lines, single-useTS-P107-A2026-03-10
04056702012052Day use tube set for irrigation, pump part, 10 applicationsTS-P508-A2026-03-10
04056702012076Patient tube for irrigation, single-useTS-P508-A2026-03-10
04056702012090Tube set for vacuum, incl. filter, 30-day useTS-P501-C2026-03-10
04056702012113Tube set for suction, single-useTS-P102-H2026-03-10
04056702012137Tube set inflow 4-Spike adaptorTS-P502-A2026-03-10
04056702012861GYN-PumpPH3042024-06-28
04056702012878Fluid Monitoring UnitPS3042024-06-28
04056702001544HEATED HUMIDIFIED TUBE SET06200503002017-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867382527Arthrex®ARTHREX, INC.FEI2023-07-07
04260206311171gastroduodenal FTRD prOVE CapOvesco Endoscopy AGFEI2020-06-05
04260206311157colonic FTRD prOVE CapOvesco Endoscopy AGFEI2019-03-08
4260206310617FTRD prOVE CapOvesco Endoscopy AGFEI2018-10-02
04260206310624FTRD prOVE CapOvesco Endoscopy AGFEI2018-10-02
00888867029330Arthrex®ARTHREX, INC.FEI2018-09-28
00885556572573NASmith & Nephew, Inc.FEI2017-08-15
00885556572467NASmith & Nephew, Inc.FEI2017-06-15
04056702002268Zoom coupler Arthrex 14-29mm C-MountW.O.M. World of Medicine GmbHFEI2016-08-19
03596010550415N/ASmith & Nephew, Inc.FEI2016-04-12
00885556600979N/ASmith & Nephew, Inc.FEI2015-10-22
00885556605547N/ASmith & Nephew, Inc.FEI2015-10-22
03596010606716NASmith & Nephew, Inc.FEI2015-10-05
03596010249302NASmith & Nephew, Inc.FEI2015-09-28
03596010541857NASmith & Nephew, Inc.FEI2015-09-28
03596010473035NASmith & Nephew, Inc.FEI2015-09-28
03596010645524NASmith & Nephew, Inc.FEI2015-09-28
03596010606709NASmith & Nephew, Inc.FEI2015-09-28
00885554024593NASmith & Nephew, Inc.FEI2015-09-28
03596010543998INTELIJETSmith & Nephew, Inc.FEI2015-08-29
23596010543992INTELIJETSmith & Nephew, Inc.FEI2015-08-29
03596010590688NASmith & Nephew, Inc.FEI2015-08-29
03596010592484NASmith & Nephew, Inc.FEI2015-08-29
03596010606785NASmith & Nephew, Inc.FEI2015-08-29
03596010610331NASmith & Nephew, Inc.FEI2015-08-29
03596010645296NASmith & Nephew, Inc.FEI2015-08-29
03596010516237NASmith & Nephew, Inc.FEI2015-08-23
03596010553386NASmith & Nephew, Inc.FEI2015-08-23
00885554006131NASmith & Nephew, Inc.FEI2015-08-23
00885554007572NASmith & Nephew, Inc.FEI2015-08-23