FDA.reportPublic FDA data

1066 OTOsuite

Primary DI
05713315000751
Brand
1066 OTOsuite
Company
Natus Medical Denmark ApS
Model
8-49-88000
Catalog number
8-49-88000
Device description
1066 OTOsuite - QUASAR (v 1.02.0248 – US only) - used with the Astera2
Published
2026-06-22
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
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315000751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315000751057133150007515713315000751

GMDN Terms#

Term, Definition table
TermDefinition
Speech audiometerAn electroacoustic device designed to measure the hearing threshold of a patient by presenting words of increasing or decreasing intensity through headphones, which the patient is required to recognize and repeat, to establish the hearing capacity of the patient and to determine if a hearing deficit exists.

Regulatory Flags#

DUNS number
306633756
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713315006890Madsen Accsucreen8-04-139778-04-139772026-07-08
05713315006906Madsen Accuscreen8-04-139788-04-139782026-07-08
05713315008610Natus8-31-2008-31-2002020-12-16
05713315008627Natus8-31-190028-31-190022020-12-16
05713315000713GN Otometrics A/SPatient Responder (Red)8-31-1902016-09-19
057133150000581052 OTOsuite8-49-758008-49-758002026-06-22
057133150007681052 OTOsuite8-49-906008-49-906002026-06-22
05713315009051Natus8-62-453008-62-453002021-04-12
05713315008689Natus1053 Freefit Charger8-62-393032021-01-04
05713315005848GN Otometrics A/SProbe Tube Holder mk28-62-608002019-04-24
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle8-62-415032016-09-19
05713315001055GN Otometrics A/SFreeFit REM probe8-69-392032016-09-19
05713315001192GN Otometrics A/SPMM RECD Probe Short8-69-392072016-09-19
05713315001208GN Otometrics A/SPMM RECD Probe Long8-69-392082016-09-19
05713315001215GN Otometrics A/SPMM RECD Probe Bin Long8-69-392092016-09-19
05713315001222GN Otometrics A/SPMM RECD Probe Bin Short8-69-392102016-09-19
05713315001246GN Otometrics A/SRECD Eartip Kit1-25-139042016-09-19
05713315001253GN Otometrics A/SRECD Fitting Kit8-62-490002016-09-19
05713315001277GN Otometrics A/SSoundHub 1008-62-423002016-09-26
05713315003301GN Otometrics A/SREM Test tubes, 1.1mm (50 pcs.)8-62-351002018-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021027Toy Cabinet (Small)INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021034Bone Vibrator w/Cable and Headband (B71)INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021089DD45-300 Headphones with Pediatric HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021096DD45-300 Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021133OAE Probe OP23INTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021218DD450 HF HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021225DD45S (10 Ohms) HeadphonesINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021232DD45S (10 Ohms) Headphones with Pediatric HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020021249DD45S (10 Ohms) Headphones with Easy Adjust HeadbandINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-10
00817020020280Capella2 OAE Start-Up KitINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021003B81 Bone VibratorINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021010B81 Bone Vibrator CableINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021164Bone Vibrator w/Cable and Headband (B81) for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00817020021171Bone Vibrator Cable for AriaINTELLIGENT HEARING SYSTEMS CORP.EWO2026-06-09
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29
05745000311187OscillaOscilla A/SEWO2026-05-29
05745000311200OscillaOscilla A/SEWO2026-05-29
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23
057117810041503000 Real EarAuditdata A/SEWO2026-01-23