FDA.reportPublic FDA data

Dornier MedTech

Primary DI
00810116020713
Brand
Dornier MedTech
Company
DORNIER MEDTECH AMERICA, INC.
Model
Axis Video Processor
Catalog number
AXPEOSB
Device description
Digital Video Processor, Input Voltage: 5V 2A (for use with Dornier Ureteroscope)
Published
2019-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180367000Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.2018-07-03FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810116020713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810116020713008101160207138101160207130810116020713

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitA mains electricity (AC-powered) device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130789944
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810116023387Dornier Axis IIDornier AXIS II E URS FLEX EU - UreteroscopeAX204082026-05-06
00810116023400Dornier MedTechDornier AXIS II D URS FLEX EU - UreteroscopeAX204132026-05-06
00810116023424Dornier MedTechDornier AXIS II CYSTO FLEX EU - UreteroscopeAX204102026-05-06
00810116023578Dornier MedTechDornier AXIS II Slim URS FLEX EU - UreteroscopeAX204162026-05-06
00810116023721Dornier MedTech Dornier Vesta Nitinol ExtractorIVX-US-F11102026-04-21
00810116023738Dornier MedTech Dornier Ceres Nitinol ExtractorIVX-US-T08102026-04-21
00810116023745Dornier MedTech Dornier Ceres Nitinol ExtractorIVX-US-T11102026-04-21
00810116023943Dornier MedTech Dornier FalconIVX-GF1-1808A2026-04-17
00810116024056Dornier MedTech AXIS II Clerix Suction URS Reverse DeflectionAX204182026-03-26
00810116024070Dornier MedTech AXIS II Clerix Suction URSAX204192026-03-26
00810116024094Dornier MedTech AXIS II Clerix Suction URSAX204202026-03-26
00810116024117Dornier MedTech AXIS II Clerix Suction URSAX204212026-03-26
00810116024049Dornier MedTech AXIS II Portable MonitorAX201002026-03-24
00810116023769Dornier HOOVER Access SheathIVX-NB-150IVX-NB-1502026-01-14
00810116023370Dornier MedTech Axis II Video ProcessorAX204072026-01-22
00810116023417Dornier MedTechDornier AXIS II D URS FLEX US - UreteroscopeAX204142026-01-22
00810116023431Dornier MedTechDornier AXIS II CYSTO FLEX US - UreteroscopeAX204112026-01-22
00810116023523Axis IIDornier AXIS II E URS FLEX US - UreteroscopeAX204092026-01-22
00810116023585Dornier MedTechAXIS II URS SLIM 7.5 FLEX SU USAX204172026-01-22
00810116023608Dornier HOOVER Access SheathIVX-NS-1040IVX-NS-10402026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
00810116023387Dornier Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023400Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023578Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.FGB2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.FGB2026-05-05
10810068811107MONARCH™ Urology Irrigation CartridgeAuris Health, Inc.FGB2026-05-04
10810068811121MONARCH™ Ureteroscope ValveAuris Health, Inc.FGB2026-05-04
00810116024056Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024070Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024094Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024117Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
06972520301216Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301223Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301230Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301247Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301254Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301261Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301278Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301285Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
00810116023370Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023417Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023523Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023585Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
06971176282924Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13