FDA.reportPublic FDA data

Sanibel Supply A/S

Primary DI
05711117217254
Brand
Sanibel Supply A/S
Company
Interacoustics A/S
Model
Sample bag - AuDX and OAE foam tips
Catalog number
8515508
Device description
Audiometric ear tip kit
Published
2024-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711117217254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711117217254057111172172545711117217254

GMDN Terms#

Term, Definition table
TermDefinition
Vestibulo-auditory analysis system support kit¿A collection of reusable/consumable devices intended to be used with a vestibulo-auditory analysis system that typically includes two or more of the following: patient electrodes, cables/leads, an ear cup, conductive gel, ear tips and cleaning wipes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306308354
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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