FDA.reportPublic FDA data

Dornier MedTech

Primary DI
00810116024049
Brand
Dornier MedTech
Company
DORNIER MEDTECH AMERICA, INC.
Model
AXIS II Portable Monitor
Catalog number
AX20100
Device description
Portable Digital Video Processor
Published
2026-03-24
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
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810116024049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810116024049008101160240498101160240490810116024049

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-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
00810116024056Dornier MedTechAXIS II Clerix Suction URS Reverse DeflectionAX204182026-03-26
00810116024070Dornier MedTechAXIS II Clerix Suction URSAX204192026-03-26
00810116024094Dornier MedTechAXIS II Clerix Suction URSAX204202026-03-26
00810116024117Dornier MedTechAXIS II Clerix Suction URSAX204212026-03-26
00810116023776Dornier MedTechBIPOLAR 12 Degree Medium Cutting Loop ElectrodeBIP12CLM2026-10-05
00810116023790Dornier MedTechBIPOLAR 12 Degree Large Cutting Loop ElectrodeBIP12CLL2026-10-05
00810116023806Dornier MedTechBIPOLAR 30 Degree Medium Cutting Loop ElectrodeBIP30CLM2026-10-05
00810116023813Dornier MedTechBIPOLAR 30 Degree Large Cutting Loop ElectrodeBIP30CLL2026-10-05
00810116023851Dornier MedTechBIPOLAR Medium Bladder Loop ElectrodeBIP12CLL2026-10-05
00810116023875Dornier MedTechBIPOLAR Needle ElectrodeBIPNEEL2026-10-05
00810116023899Dornier MedTechBIPOLAR Dornier Plasma Disc ElectrodeBIPDDSC2026-10-05
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
00810116023769Dornier HOOVER Access SheathIVX-NB-150IVX-NB-1502026-01-14

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