FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315003530
Brand
GN Otometrics A/S
Company
NATUS MANUFACTURING LIMITED
Model
1012, Ear Tip Kit, 7mm, 50 pcs
Catalog number
8-68-31504
Device description
Silicone Eartip, 7mm, semi red, mushroom
Published
2018-07-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ETTCushion, Earphone (For Audiometric Testing)
ETYTester, Auditory Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETTCushion, Earphone (For Audiometric Testing)Ear, Nose, Throat1
ETYTester, Auditory ImpedanceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033645000OTOFLEX 100 TYE 1012Gn Otometrics A/S2004-03-31ETY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315003530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315003530057133150035305713315003530

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
896421240
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830049405Natus9033B07212024-04-19
00382830049412Natus9033B07312024-04-19
00382830047722Natus 9031E27222020-07-08
00382830047746Keypoint9013L02419013L02412019-03-11
00382830049436Natus9033B07612024-04-19
00382830049078Keypoint9031E02239031E02232019-03-11
00382830050401Keypoint9031E02589031E02582019-03-13
00382830050418Keypoint9031E02779031E02772019-03-13
00382830050425Keypoint9031E04029031E04022019-03-13
00382830017237GrassF-E2-122016-08-25
00382830017244GrassF-E2-242016-08-25
00382830017251GrassF-E2-302016-08-25
00382830017268GrassF-E2-482016-08-25
00382830017275GrassF-E2-722016-08-25
00382830043601GrassF-E2-122016-08-25
00382830043618GrassF-E2-242016-08-25
00382830043625GrassF-E2-302016-08-25
05704736002868Dantec9013S00222016-08-25
05704736002875Dantec9013S00322016-08-25
05704736002882Dantec9013S00422016-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713315009402Madsen ZodiacNatus Medical Denmark ApSETY2026-06-02
B43061000100GoCheck Audiometric Headphone AssemblyGobiquity, Inc.ETT2026-06-02
04260223142994Sentiero Desktop DiagnosticPATH medical GmbHETY2024-05-22
10840162500317Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500324Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
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10840162500355Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
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