Sanibel Supply A/S 8533304 (50 pcs)

GUDID 05711117228571

Accessory for Real Ear Measurement (REM), red

Interacoustics A/S

Audiometric/hearing aid tester
Primary Device ID05711117228571
NIH Device Record Keye2390fef-67f1-4ec6-991a-ae09c995722a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSanibel Supply A/S
Version Model NumberSanibel REM Probe Tubes, type D
Catalog Number8533304 (50 pcs)
Company DUNS306308354
Company NameInteracoustics A/S
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105711117227581 [Primary]
GS105711117228533 [Unit of Use]
GS105711117228571 [Package]
Contains: 05711117227581
Package: [10 Units]
In Commercial Distribution

FDA Product Code

ETWCalibrator, Hearing Aid / Earphone And Analysis Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-07
Device Publish Date2022-11-29

On-Brand Devices [Sanibel Supply A/S]

05711117221022Circumaural Coupler
05711117228571Accessory for Real Ear Measurement (REM), red
05711117228564Accessory for Real Ear Measurement (REM), blue
05711117228557Accessory for Real Ear Measurement (REM), black
05711117217704Circumaural Coupler
05711117131086Jumper electrode cable, 125mm
05711117105414Electrode cable for TM Electrode
05711117019100ETB Titan standard electrode cable kit/3pcs (BRW), 500mm
05711117019025ETB standard electrode cable kit/5pcs (BRWYB), 500mm
05711117227413Button electrode cable kit/5pcs (RWBYK), 500mm
05711117227406Button electrode cable kit/3pcs (RWB), 500mm
05711117219012Pinch clip electrode cable kit/3 pcs (WYK), 1000mm
05711117218145Alligator electrode cable kit/5pcs, (RWBYK), 500mm
05711117218121Alligator clip electrode cable kit/3pcs (RWB), 500 mm
05711117199987Alligator clip electrode cable kit/3pcs (WYK), 500mm
05711117095937Pinch clip electrode cable kit/5pcs (BRWKY)
05711117095920Pinch clip electrode cable kit/3pcs (WKY)
05711117095913Pinch clip electrode cable kit/3pcs (BRW)
05711117229066Button electrode cable RGKW +Jumper
05711117229059Button electrode cable, RWGK
05711117229028Alligator clip electrode cable, RYW
05711117229011Alligator clip electrode cable, RWBYK
05711117229004Alligator clip electrode cable, RWBYK
05711117226478Accessory for Real Ear Measurement (REM)
05711117094206Accessory for Real Ear Measurement (REM), orange
05711117232042Gold Eartip Electrode
05711117098389Gold Eartip Electrode
05711117243772DD450 High Frequency Headset CH 3.5mm 3Poles plug + Mini 4 Pins male connector
05711117243765DD450 High Frequency Headset CH 30° 6.3mm x2 2Poles WITH MEMORY + Mini 4Pins male connector
05711117243758DD450 High Frequency Headset CH 3.5mm 3Poles plug 90 degrees + Mini 4 Pins male connector
05711117243741DD450 High Frequency Headset CH 6.3mmx2 2Poles + Mini 4Pins male connector
05711117243734DD450 High Frequency Headset CH Din 8 Pins + Mini 4Pins male connector
05711117243727DD450 High Frequency Headset CH 30° 6.3mm x2 2Poles Mini 4Pins male connector
05711117217254Audiometric ear tip kit
05711117244168Foam ear tip 10 mm, ER1/ER2
05711117244175Foam ear tip 13 mm, ER10C
05711117244205Foam ear tip 13 mm, ER10B+
05711117244199Foam ear tip 18 mm, ER10C
05711117244182Foam ear tip 10 mm, ER10C
05711117244151Foam ear tip 13 mm, ER1/ER2
05711117228458Black, sample kit. Accessory for Real Ear Measurement (REM)
05711117245127ER10C-06
05711117245110ER10C-05
05711117245103ER10C-04
05711117245097ER10C-03
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.