FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315000331
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
Hearing Instrument Programmer
Catalog number
8-04-14800
Device description
1072 HI-PRO 2
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air Conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315000331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315000331057133150003315713315000331

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
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
057133150123581082 Aurical HIT9-04-151019-04-151012026-10-28
057133150123651053 Aurical Freefit9-62-491009-62-491002026-10-28
05713315012389GN Otometrics A/S1053 PMM, RECD Probe, Long (2pcs)9-69-392102026-10-28
057133150123961053 Aurical Freefit9-04-118089-04-118082026-10-28
057133150124021053 Aurical FreeFit9-62-453009-62-453002026-10-28
057133150124261053 AUrical Freefit9-04-118209-04-118202026-10-28
057133150124331053 Aurical Freefit9-62-491109-62-491102026-10-28
057133150124401081 Aurical Aud9-04-145309-04-145302026-10-28
05713315012532GN Otometrics A/S1053 PMM RECD Probe, Long9-69-392062026-10-28
05713315010996AccuScreen Earcouplers0465850465852026-10-14
05713315011009AccuScreen Earcouplers0462000462002026-10-14
05713315012297Disposable Snap Electrodes (25 x 3 pack)0521630521632026-10-14
05713315012303Disposable Snap Electrodes (3 pack)0521650521652026-10-14
05713315012341Aurical Otocam 300-III10768-04-132602026-07-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E239831001FotoTec® RepairDreve Otoplastik GmbHESD2026-10-14
05708296382927BeltoneGn Hearing A/SESD2026-02-10
05708296382934BeltoneGn Hearing A/SESD2026-02-10
05708296382941BeltoneGn Hearing A/SESD2026-02-10
05708296383061BeltoneGn Hearing A/SESD2026-02-10
05708296383078BeltoneGn Hearing A/SESD2026-02-10
05708296383085BeltoneGn Hearing A/SESD2026-02-10
05708296383207BeltoneGn Hearing A/SESD2026-02-10
05708296383214BeltoneGn Hearing A/SESD2026-02-10
05708296383221BeltoneGn Hearing A/SESD2026-02-10
05708296383344BeltoneGn Hearing A/SESD2026-02-10
05708296383351BeltoneGn Hearing A/SESD2026-02-10
05708296383368BeltoneGn Hearing A/SESD2026-02-10
05708296383481GN ReSoundGn Hearing A/SESD2026-02-10
05708296383498GN ReSoundGn Hearing A/SESD2026-02-10
05708296383504GN ReSoundGn Hearing A/SESD2026-02-10
05708296383627GN ReSoundGn Hearing A/SESD2026-02-10
05708296383634GN ReSoundGn Hearing A/SESD2026-02-10
05708296383641GN ReSoundGn Hearing A/SESD2026-02-10
05708296383764GN ReSoundGn Hearing A/SESD2026-02-10
05708296383771GN ReSoundGn Hearing A/SESD2026-02-10
05708296383788GN ReSoundGn Hearing A/SESD2026-02-10
05708296383900GN ReSoundGn Hearing A/SESD2026-02-10
05708296383917GN ReSoundGn Hearing A/SESD2026-02-10
05708296383924GN ReSoundGn Hearing A/SESD2026-02-10
05708296385300GN ReSoundGn Hearing A/SESD2026-02-10
05708296385317GN ReSoundGn Hearing A/SESD2026-02-10
05708296385324GN ReSoundGn Hearing A/SESD2026-02-10
05708296411313BeltoneGn Hearing A/SESD2026-02-10
05708296411320BeltoneGn Hearing A/SESD2026-02-10