FDA.reportPublic FDA data

Sanibel Supply

Primary DI
05711117229783
Brand
Sanibel Supply
Company
Interacoustics A/S
Model
TM electrode for ECochG, starter kit
Catalog number
8013209
Device description
Medical device accessories intended for ABR measurements
Published
2022-12-29
Public version status
New
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711117229783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711117229783057111172297835711117229783

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential audiometerAn electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity60 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius27 Degrees Celsius
Storage Environment Temperature60 Degrees Fahrenheit80 Degrees Fahrenheit

Regulatory Flags#

DUNS number
306308354
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05711117244540InteracousticsSera2026-07-28
05711117244557InteracousticsTitan2026-07-28
05711117230796Sanibel Supply A/SSanibel EARturtle Universal85372062026-05-14
05711117230802Sanibel Supply A/SSanibel EARturtle Universal Box of 36 kits w/tab e85372092026-05-14
05711117244304Sanibel Supply A/SSanibel EARturtle Universal Box of 36 kits w/snap 86025002026-05-14
05711117244991InteracousticsVisualEyes 5052025-08-14
05711117245004InteracousticsVisualEyes EyeSeeCam vHIT2025-08-14
05711117245028InteracousticsVisualEyes 5252025-08-14
05711117230833Sanibel Supply A/SER10C-0385372382025-08-07
05711117230840Sanibel Supply A/SER10C-0485372392025-08-07
05711117230857Sanibel Supply A/SER10C-0585372402025-08-07
05711117230864Sanibel Supply A/SER10C-0685372412025-08-07
05711117245097Sanibel Supply A/SER10C-0385372382025-08-07
05711117245103Sanibel Supply A/SER10C-0485372392025-08-07
05711117245110Sanibel Supply A/SER10C-0585372402025-08-07
05711117245127Sanibel Supply A/SER10C-0685372412025-08-07
05711117008395Sanibel SupplyEar tip, OAE-4 ER Infant, 4 mm red flanged2022-12-08
05711117226089Sanibel SupplyEar tip infant 4 mm, ANA-4.0, blue2022-12-08
05711117226096Sanibel SupplyEar tip infant 5 mm, ANA-5.0, green2022-12-08
05711117226102Sanibel SupplyEar tip infant 4,5 mm, ANA-4.5, red-brown2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223148057Ear Coupler (Transparent) SetPATH medical GmbHGWJ2026-08-19
04260223147753Ear Coupler TR 30 pairsPATH medical GmbHGWJ2026-07-29
05711117244540InteracousticsInteracoustics A/SGWJ2026-07-28
05711117244557InteracousticsInteracoustics A/SGWJ2026-07-28
04260223145995Ear Coupler SetPATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
04260223148002Accessory box AB-LT02PATH medical GmbHGWJ2026-07-24
05713315006890Madsen AccsucreenNatus Medical Denmark ApSGWJ2026-07-08
05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWJ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWJ2026-07-07
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
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00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
B592SW100WAVi Scan SoftwareWAVI CO.GWJ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWJ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWJ2026-03-25
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22