FDA.reportPublic FDA data

Madsen Zodiac

Primary DI
00571331500946
Brand
Madsen Zodiac
Company
Gn Otometrics A/S
Model
8-04-16307
Catalog number
8-04-16307
Device description
1096 Zodiac PC QC
Published
2022-12-05
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
ETYTester, Auditory Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00571331500946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00571331500946005713315009465713315009460571331500946

GMDN Terms#

Term, Definition table
TermDefinition
Impedance audiometerAn electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
05713315008658Natus 8-66-225008-66-225002020-12-17
05713315008566Otometrics1085, FACE CUSHION 2 ASM KIT8-35-501002020-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051597160051ResonanceM.R.S. SRLETY2025-09-01
08051597160099ResonanceM.R.S. SRLETY2025-09-01
04260223142994Sentiero Desktop DiagnosticPATH medical GmbHETY2024-05-22
05060488902673Amplivox AMPLIVOX LIMITEDETY2024-01-08
05060488902635Amplivox AMPLIVOX LIMITEDETY2023-12-22
05060488902680Amplivox AMPLIVOX LIMITEDETY2023-12-22
00732094082760Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084580Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084597Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084702Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084719Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084726Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
00732094084733Welch Allyn, Inc.WELCH ALLYN, INC.ETY2023-08-17
05713315009396Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009907Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009914Madsen ZodiacNatus Medical Denmark ApSETY2022-12-15
05713315009389Madsen ZodiacNatus Medical Denmark ApSETY2022-12-12
05713315009464Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
05713315009419Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
05713315009440Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
05713315009495Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
05713315009563Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
05713315009648Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
05713315009723Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
05713315009778Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
05713315009846Madsen ZodiacNatus Medical Denmark ApSETY2022-12-05
04260223143700TY-MAPATH medical GmbHETY2022-01-17
04260223143717TY-MA Set PATH medical GmbHETY2022-01-17
05713315009013MadsenNatus Medical Denmark ApSETY2021-08-11
05711117180282InteracousticsInteracoustics A/SETY2021-06-03