OTOPRONT

Primary DI
04260154546205
Brand
OTOPRONT
Company
Happersberger Otopront GmbH
Model
VARIO
Published
2026-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ETPStimulator, Caloric-Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETPStimulator, Caloric-WaterEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260154546205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260154546205042601545462054260154546205

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic caloric vestibular stimulation systemAn assembly of devices intended to evaluate a patient’s vestibular function through the application of heat and/or cold stimuli in the form of a stream of air or water into the ear canal, whereby involuntary horizontal eye movements (nystagmus) are produced and measured using a nystagmograph. The procedure may also be referred to as caloric reflex test, and is typically used for assessing a patient's balance system and/or to test for brainstem death. It typically consists of an irrigation system that includes a pump, valves, heaters and regulators to control the rate of flow and temperature of the medium. This device is typically used in an ear/nose/throat (ENT) department.

Regulatory Flags#

DUNS number
315858175
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260154547271OTOPRONTRigid Endoscope otopront 0°2026-07-08
04260154547400OTOPRONTRigid Endoscope otopront 0°2026-07-08
04260154547417OTOPRONTRigid Endoscope otopront 30°2026-07-08
04260154547424OTOPRONTRigid Endoscope otopront 70°2026-07-08
04260154547448OTOPRONTRigid Endoscope otopront 0°2026-07-08
04260154547455OTOPRONTRigid Endoscope otopront 0°2026-07-08
04260154547462OTOPRONTRigid Endoscope otopront 30°2026-07-08
04260154547479OTOPRONTRigid Endoscope otopront 30°2026-07-08
04260154547486OTOPRONTRigid Endoscope otopront 70°2026-07-08
04260154547493OTOPRONTRigid Endoscope otopront 70°2026-07-08
04260154547530OTOPRONTRigid Endoscope otopront 30°2026-07-08
04260154540234OTOPRONTPES Eco HD2024-12-02
04260154540241OTOPRONTPES Eco HD2024-12-02
04260154540258OTOPRONTSIT MAX one2024-12-02
04260154540012OTOPRONTSMART2023-07-04
04260154541002OTOPRONTBASIC PLUS2023-07-04
04260154541019OTOPRONTBASIC PLUS2023-07-04
04260154541026OTOPRONTBASIC PLUS2023-07-04
04260154541309OTOPRONTBASIC PLUS2023-07-04
04260154541606OTOPRONTBASIC PLUS2023-07-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250365142273ATMOSATMOS MedizinTechnik GmbH & Co. KGETP2024-11-27
04250365142297ATMOSATMOS MedizinTechnik GmbH & Co. KGETP2024-11-27
05711117199574InteracousticsInteracoustics A/SETP2022-04-12
B516174730Instrumentation DifraInstrumentation Difra SAETP2020-05-18
B516175500Instrumentation DifraInstrumentation Difra SAETP2020-05-18
B51617473Instrumentation DifraInstrumentation Difra SAETP2018-09-17
B51617550Instrumentation DifraInstrumentation Difra SAETP2018-09-17