GN Otometrics A/S

Primary DI
05713315000416
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
Eartip 6-9 mm Blue Tree (Bag of 250 pcs.)
Published
2016-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132957000MADSEN ACCUSCREEN TYPE 1077Gn Otometrics2014-02-27GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315000416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315000416057133150004165713315000416

GMDN Terms#

Term, Definition table
TermDefinition
Auditory stimulatorA mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306633756
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05713315004100GN Otometrics A/SAurical FreeFit, Complete Solution8-04-118082016-09-19
05713315004117GN Otometrics A/SAurical FreeFit, Complete Solution8-62-491002016-09-19
05713315005701GN Otometrics A/SREM Tube with ruler8-62-610002018-11-06
05713315008184GN Otometrics A/SOTOair 2 Bluetooth Dongle8-62-649002019-03-18
00571331500960Madsen Zodiac8-04-163218-04-163212026-06-04
05713315009587Madsen Zodiac8-04-163198-04-163192026-06-04
05713315009594Madsen Zodiac8-04-163208-04-163202026-06-04

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