FDA.reportPublic FDA data

Sanibel Supply A/S

Primary DI
05711117228458
Brand
Sanibel Supply A/S
Company
Interacoustics A/S
Model
Sanibel REM Probe Tubes, type A
Device description
Black, sample kit. Accessory for Real Ear Measurement (REM)
Published
2024-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
ETWCalibrator, Hearing Aid / Earphone And Analysis Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETWCalibrator, Hearing Aid / Earphone And Analysis SystemsEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711117244335PrimaryGS10
05711117228458Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711117244335057111172443355711117244335
05711117228458057111172284585711117228458

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing aid tester support kitA collection of devices and supplies designed to facilitate the use of an audiometric/hearing aid tester that typically includes two or more of the following: a real-ear probe tube, ear tips and cleaning wipes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306308354
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
05711117226119Sanibel SupplyEar tip 5 mm, AOT-5.0 light blue2022-12-08
05711117226126Sanibel SupplyEar tip 4 mm, AOT-4.0 green2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05711781004297Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004372Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004006Unity 3Auditdata A/SETW2024-10-21
05711117244335Sanibel Supply A/SInteracoustics A/SETW2024-10-07
00810044583182MedRxMEDRX, INC.ETW2024-05-07
EADF03410600217207189audifonaudifon GmbH & Co. KGETW2023-03-31
05711117121742Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117094206Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117226478Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117227550Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227574Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227581Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228557Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228564Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228571Sanibel Supply A/SInteracoustics A/SETW2022-11-29
EADF034106002172068681audifonaudifon GmbH & Co. KGETW2022-10-21
05713315009037NatusNatus Medical Denmark ApSETW2021-04-12
05713315009044NatusNatus Medical Denmark ApSETW2021-04-12
05713315009051NatusNatus Medical Denmark ApSETW2021-04-12
05713315008689NatusNatus Medical Denmark ApSETW2021-01-04
B161RE3670Audioscan Probe TubeEtymonic Design IncorporatedETW2020-01-15
05711117198218InteracousticsInteracoustics A/SETW2019-11-26
B161VA3000Verifit Skull SimulatorEtymonic Design IncorporatedETW2019-05-02
B161VA3003Verifit Skull SimulatorEtymonic Design IncorporatedETW2019-05-02
05713315005848GN Otometrics A/SNatus Medical Denmark ApSETW2019-04-24
05713315008184GN Otometrics A/SNatus Medical Denmark ApSETW2019-03-18
05713315005701GN Otometrics A/SNatus Medical Denmark ApSETW2018-11-06
05713315003301GN Otometrics A/SNatus Medical Denmark ApSETW2018-07-31
08054187380730DRUMINVENTIS SRLETW2017-08-24
08054187380617TRUMPETINVENTIS SRLETW2016-11-23